Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05457556




Registration number
NCT05457556
Ethics application status
Date submitted
11/07/2022
Date registered
14/07/2022
Date last updated
22/04/2024

Titles & IDs
Public title
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
Scientific title
A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)
Secondary ID [1] 0 0
NCI-2022-07080
Secondary ID [2] 0 0
ASCT2031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Acute Myeloid Leukemia 0 0
Mixed Phenotype Acute Leukemia 0 0
Myelodysplastic Syndrome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Biospecimen Collection
Treatment: Surgery - Bone Marrow Aspiration
Treatment: Drugs - Busulfan
Treatment: Drugs - Cyclophosphamide
Treatment: Surgery - Echocardiography
Treatment: Drugs - Fludarabine
Treatment: Surgery - Haploidentical Hematopoietic Cell Transplantation
Other interventions - Lapine T-Lymphocyte Immune Globulin
Treatment: Surgery - Lumbar Puncture
Treatment: Surgery - Matched Unrelated Donor Hematopoietic Cell Transplantation
Treatment: Drugs - Melphalan
Treatment: Drugs - Methotrexate
Treatment: Surgery - Multigated Acquisition Scan
Treatment: Drugs - Mycophenolate Mofetil
Treatment: Surgery - Myeloablative Conditioning
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration
Other interventions - Rituximab
Treatment: Surgery - T-Cell Depletion Therapy
Treatment: Drugs - Tacrolimus
Treatment: Drugs - Thiotepa
Treatment: Other - Total-Body Irradiation

Experimental: Arm A (halploHCT) - Patients receive a myeloablative conditioning regimen with PTCy or alpha beta T cell depletion at the discretion of the treating provider. Patients then undergo haploHCT on day 0. Patients undergoing myeloablative conditioning regimen with PTCy also receive GVHD prophylaxis on days 3-5. Patients undergo lumbar puncture, bone marrow aspiration, and ECHO or MUGA during screening. Patients also undergo collection of blood throughout the trial.

Experimental: Arm B (MUD-HCT) - Patients receive a TBI-based or chemotherapy-based myeloablative conditioning regimen between days -9 and -2, followed by MUD-HCT on day 0. Patients then receive GVHD prophylaxis regimen on days 1-11. Patients undergo lumbar puncture, bone marrow aspiration, and ECHO or MUGA during screening. Patients also undergo collection of blood throughout the trial.

Experimental: Arm C (haploHCT) - Patients who only have a haplo donor receive a myeloablative conditioning regimen with PTCy or alpha beta T cell depletion at the discretion of the treating provider. Patients then undergo haploHCT on day 0. Patients undergoing myeloablative conditioning regimen with PTCy also receive GVHD prophylaxis on days 3-5. Patients undergo lumbar puncture, bone marrow aspiration, and ECHO or MUGA during screening. Patients also undergo collection of blood throughout the trial.


Treatment: Surgery: Biospecimen Collection
Undergo collection of blood

Treatment: Surgery: Bone Marrow Aspiration
Undergo bone marrow aspiration

Treatment: Drugs: Busulfan
Given intravenously (IV)

Treatment: Drugs: Cyclophosphamide
Given IV

Treatment: Surgery: Echocardiography
Undergo ECHO

Treatment: Drugs: Fludarabine
Given IV

Treatment: Surgery: Haploidentical Hematopoietic Cell Transplantation
Undergo haploHCT

Other interventions: Lapine T-Lymphocyte Immune Globulin
Given IV

Treatment: Surgery: Lumbar Puncture
Undergo lumbar puncture

Treatment: Surgery: Matched Unrelated Donor Hematopoietic Cell Transplantation
Undergo MUD-HCT

Treatment: Drugs: Melphalan
Given IV

Treatment: Drugs: Methotrexate
Given IV

Treatment: Surgery: Multigated Acquisition Scan
Undergo MUGA

Treatment: Drugs: Mycophenolate Mofetil
Given IV

Treatment: Surgery: Myeloablative Conditioning
Receive myeloablative conditioning regimen

Other interventions: Quality-of-Life Assessment
Ancillary studies

Other interventions: Questionnaire Administration
Ancillary studies

Other interventions: Rituximab
Given IV

Treatment: Surgery: T-Cell Depletion Therapy
Undergo haploHCT with alpha beta T cell depletion

Treatment: Drugs: Tacrolimus
Given IV

Treatment: Drugs: Thiotepa
Given IV

Treatment: Other: Total-Body Irradiation
Undergo TBI
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Intervention code [4] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severe GVHD (Grade III-IV acute GVHD or chronic GVHD requiring systemic immunosuppressive therapy)
Timepoint [1] 0 0
Up-to 1-year post hematopoietic cell transplantation (HCT)
Primary outcome [2] 0 0
Disease free survival (DFS) (where an event is the occurrence of death from any cause or relapse)
Timepoint [2] 0 0
From date of randomization to up-to 1 year post randomization
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
From date of randomization to up-to 1-year post-HCT
Secondary outcome [2] 0 0
Summary score from the Generic Pediatric Quality of Life Inventory (PedsQL) (excluding School Functioning)
Timepoint [2] 0 0
At 6-months, 1 year and 2 years post-HCT
Secondary outcome [3] 0 0
Summary score from the PedsQL Stem Cell Transplant module
Timepoint [3] 0 0
6-months, 1 year and 2 years post-HCT

Eligibility
Key inclusion criteria
- PATIENT INCLUSION CRITERIA FOR ENROLLMENT:

- 6 months to < 22 years at enrollment

- Diagnosed with ALL, AML, or MDS or mixed phenotype acute leukemia (MPAL) for which an
allogeneic hematopoietic stem cell transplant is indicated. Complete Remission (CR)
status will not be confirmed at the time of enrollment. CR as defined in these
sections is required to proceed with the actual HCT treatment plan

- Has not received a prior allogeneic hematopoietic stem cell transplant

- Does not have a suitable human leukocyte antigen (HLA)-matched sibling donor available
for stem cell donation

- Has an eligible haploidentical related family donor based on at least intermediate
resolution HLA typing

- Patients who also have an eligible 8/8 MUD adult donor based on confirmatory high
resolution HLA typing are eligible for randomization to Arm A or Arm B.

- Patients who do not have an eligible MUD donor are eligible for enrollment to Arm
C

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

- Co-Enrollment on other trials

- Patients will not be excluded from enrollment on this study if already enrolled
on other protocols for treatment of high risk and/or relapsed ALL, AML, MPAL and
MDS. This is including, but not limited to, COG AAML1831, COG AALL1821, the
EndRAD Trial, as well as local institutional trials. We will collect information
on all co-enrollments

- Patients will not be excluded from enrollment on this study if receiving
immunotherapy prior to transplant as a way to achieve remission and bridge to
transplant. This includes chimeric antigen receptor (CAR) T cell therapy and
other immunotherapies

- PATIENT INCLUSION CRITERIA TO PROCEED TO HCT:

- Karnofsky Index or Lansky Play-Performance Scale >= 60 on pre-transplant evaluation.
Karnofsky scores must be used for patients >= 16 years of age and Lansky scores for
patients =< 16 years of age (within 4 weeks of starting therapy)

- A serum creatinine based on age/gender as follows:

6 months to < 1 year: 0.5 mg/dL (Male); 0.5 mg/dL (Female)

1. to < 2 years: 0.6 mg/dL (Male); 0.6 mg/dL (Female)

2. to < 6 years: 0.8 mg/dL (Male); 0.8 mg/dL (Female)

6 to < 10 years: 1 mg/dL (Male); 1 mg/dL (Female) 10 to < 13 years: 1.2 mg/dL (Male);
1.2 mg/dL (Female) 13 to < 16 years: 1.5 mg/dL (Male); 1.4 mg/dL (Female) >= 16 years:
1.7 mg/dL (Male); 1.4 mg/dL (Female)

- OR

- A 24 hour urine Creatinine clearance >= 60 mL/min/1.73 m^2

- OR

- A glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2. GFR must be performed using
direct measurement with a nuclear blood sampling method OR direct small molecule
clearance method (iothalamate or other molecule per institutional standard)

- Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates
are not acceptable for determining eligibility

- Serum glutamic-oxaloacetic transaminase (SGOT) aspartate aminotransferase [AST] or
serum glutamate pyruvate transaminase (SGPT) aminotransferase [ALT] < 5 x upper limit
of normal (ULN) for age

- Total bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome

- Shortening fraction of >= 27% by echocardiogram or radionuclide scan (MUGA)

- OR

- Ejection fraction of >= 50% by echocardiogram or radionuclide scan (MUGA), choice of
test according to local standard of care

- Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and
corrected carbon monoxide diffusing capability (DLCO) must all be >= 50% of predicted
by pulmonary function tests (PFTs).

- For children who are unable to perform for PFTs (e.g., due to age or
developmental delay), the criteria are: no evidence of dyspnea at rest, oxygen
(O2) saturation (Sat) > 92% on room air by pulse oximetry, not on supplemental O2
at rest, and not on supplemental O2 at rest

- MPAL in first complete remission (CR1) for whom transplant is indicated. Examples
include those patients who are poorly responsive to ALL therapy (end of induction
failure( IF-MPAL) to ALL induction (see IF-MPAL note below), end of induction MRD = 5%
or end-of-consolidation MRD > 0.01%), as well as patients treated with AML therapy

- IF-MPAL: additional criterion for Induction failure for MPAL ONLY as per ALL1732:

- An increasing number of circulating leukemia cells on 3 or more consecutive CBCs
obtained at daily or longer intervals following day 8 of Induction therapy and
prior to day 29 with confirmation by flow cytometry OR development of new sites
of extramedullary disease, or other laboratory or clinical evidence of refractory
disease or progression prior to the end of Induction evaluation (note that
residual testicular disease at the end of Induction is an exception)

- MPAL in > second complete remission (CR2)

- ALL high-risk in CR1 for whom transplant is indicated. Examples include: induction
failure, treatment failure as per minimal residual disease by flow cytometry > 0.01%
after consolidation and not eligible for AALL1721 or AALL1721 not available/unwilling
to enroll, hypodiploidy (< 44 chromosomes) with MRD+ > 0.01% after induction,
persistent or recurrent cytogenetic or molecular evidence of disease during therapy
requiring additional therapy after induction to achieve remission (e.g. persistent
molecular BCR-ABL positivity), T cell ALL with persistent MRD > 0.01% after
consolidation.

- ALL in CR2 for whom transplant is indicated. Examples include: B-cell: early (=< 36
months from initiation of therapy) bone marrow (BM) relapse, late BM relapse (>= 36
months) with MRD >= 0.1% by flow cytometry after first re-induction therapy; T or
B-cell: early (< 18 months) isolated extramedullary (IEM), late (>= 18 months) IEM,
end-Block 1 MRD >= 0.1%; T-cell or Philadelphia chromosome positive (Ph+): BM relapse
at any time

- ALL in >= third complete remission (CR3)

- Patients treated with chimeric antigen receptor T-cells (CART) cells for whom
transplant is indicated. Examples include: transplant for consolidation of CART, loss
of CART persistence and/or B cell aplasia < 6 months from infusion or have other
evidence (e.g., MRD+) that transplant is indicated to prevent relapse

- AML in CR1 for whom transplant is indicated. Examples include those deemed high risk
for relapse as described in AAML1831:

- FLT3/ITD+ with allelic ratio > 0.1 without bZIP CEBPA, NPM1

- FLT3/ITD+ with allelic ratio > 0.1 with concurrent bZIP CEBPA or NPM1 and with
evidence of residual AML (MRD >= 0.05%) at end of Induction

- Presence of RAM phenotype or unfavorable prognostic markers (other than FLT3/ITD)
per cytogenetics, fluorescence in situ hybridization (FISH), next generation
sequencing (NGS) results, regardless of favorable genetic markers, MRD status or
FLT3/ITD mutation status

- AML without favorable or unfavorable cytogenetic or molecular features but with
evidence of residual AML (MRD >= 0.05%) at end of Induction

- Presence of a non-ITD FLT3 activating mutation and positive MRD (>= 0.05%) at end
of Induction 1 regardless of presence of favorable genetic markers.

- AML in >= CR2

- MDS with < 5% blasts by morphology and flow cytometry (if available) on the
pre-transplant bone marrow evaluation

- Complete remission (CR) is defined as < 5% blasts by morphology and flow cytometry (if
available) on the pre-transplant bone marrow evaluation with minimum sustained
absolute neutrophil count (ANC) of 300 cells/microliter for 1 week or ANC > 500
cells/microliter. We will be collecting data from all approaches to MRD evaluation
performed including NGS and polymerase chain reaction (PCR). It is strongly
recommended that MPAL be evaluated using multidimensional flow cytometry and/or
(KMT2Ar) qt PCR. It is strongly recommended that MPAL be evaluated using
multidimensional flow cytometry and/or (KMT2Ar) qt PCR

- DONOR ELIGIBILITY CRITERIA:

- Matched Unrelated Donors:

Unrelated donor candidates must be matched at high resolution at a minimum of 8/8 alleles
(HLA-A, -B, -C, -DRB1). One-antigen HLA mismatches are not permitted. HLA matching of
additional alleles is recommended according to National Marrow Donor Program (NMDP)
guidelines, but will be at the discretion of local centers

- Haploidentical Matched Family Members:

- Minimum match level full haploidentical (at least 5/10; HLA-A, -B, -C, -DRB1,
-DQB1 alleles). The following issues (in no particular order) should be
considered in choosing a haploidentical donor:

- Absent or low patient donor-specific antibodies (DSA)

- Mean fluorescence intensity (MFI) of any anti-donor HLA antibody by
solid phase immunoassay should be < 2000. Donors with higher levels are
not eligible.

- If a screening assay against pooled HLA antigens is used, positive
results must be followed with specificity testing using a single
antigen assay. The MFI must be < 2000 unless the laboratory has
validated higher threshold values for reactivity for HLA antigens
(such as HLA-C, -DQ, and -DP), that may be enhanced in
concentration on the single antigen assays. Donor anti- recipient
antibodies are of unknown clinical significance and do not need to
be sent or reported.

- Consult with Study Chair for the clinical significance of any
recipient anti-donor HLA antibody.

- If centers are unable to perform this type of testing, please
contact the Study Chair to make arrangements for testing.

- If killer immunoglobulin testing (KIR) is performed: KIR status by mismatch,
KIR-B, or KIR content criteria can be used according to institutional
guidelines.

- ABO compatibility (in order of priority):

- Compatible or minor ABO incompatibility

- Major ABO incompatibility

- CMV serostatus:

- For a CMV seronegative recipient: the priority is to use a CMV
seronegative donor when feasible

- For a CMV seropositive recipient: the priority is to use a CMV
seropositive donor when feasible

- Age: younger donors including siblings/half-siblings, and second degree
relatives (aunts, uncles, cousins) are recommended, even if < 18 years

- Size and vascular access appropriate by center standard for peripheral blood stem cell
(PBSC) collection if needed

- Haploidentical matched family members: screened by center health screens and found to
be eligible

- Unrelated donors: meet eligibility criteria as defined by the NMDP or other unrelated
donor registries. If the donor does not meet the registry eligibility criteria but an
acceptable eligibility waiver is completed and signed per registry guidelines, the
donor will be considered eligible for this study

- Human immunodeficiency virus (HIV) negative

- Not pregnant

- MUD donors and post-transplant cyclophosphamide haplo donors should be asked to
provide BM. If donors refuse and other donors are not available, PBSC is allowed.
TCR-alpha beta/CD19 depleted haplo donors must agree to donate PBSC

- Must give informed consent:

- Haploidentical matched family members: Institution standard of care donor consent
and Protocol-specific Donor Consent for Optional Studies

- Unrelated donors: standard NMDP Unrelated Donor Consent
Minimum age
6 Months
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- PATIENT EXCLUSION CRITERIA FOR ENROLLMENT:

- Patients with genetic disorders (generally marrow failure syndromes) prone to
secondary AML/ALL/MPAL with known poor outcomes because of sensitivity to alkylator
therapy and/or TBI are not eligible (Fanconi Anemia, Kostmann Syndrome, Dyskeratosis
Congenita, etc). Patients with Downs syndrome because of increased toxicity with
intensive conditioning regimens.

- Patients with any obvious contraindication to myeloablative HCT at the time of
enrollment

- Female patients who are pregnant are ineligible as many of the medications used in
this protocol could be harmful to unborn children and infants

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation

- PATIENT EXCLUSION CRITERIA TO PROCEED TO HCT:

- Patients with uncontrolled fungal, bacterial, viral, or parasitic infections are
excluded. Patients with history of fungal disease during chemotherapy may proceed if
they have a significant response to antifungal therapy with no or minimal evidence of
disease remaining by computed tomography (CT) evaluation

- Patients with active central nervous system (CNS) leukemia or any other active site of
extramedullary disease at the time of initiation of the conditioning regimen are not
permitted.

- Note: Those with prior history of CNS or extramedullary disease, but with no
active disease at the time of pre-transplant workup, are eligible

- Pregnant or breastfeeding females are ineligible as many of the medications used in
this protocol could be harmful to unborn children and infants

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
435
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
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Colorado
Country [6] 0 0
United States of America
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Connecticut
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United States of America
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Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
Country [12] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Mississippi
Country [18] 0 0
United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Wisconsin
Country [31] 0 0
Canada
State/province [31] 0 0
Manitoba
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using
mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in
treating children, adolescents, and young adults with acute leukemia or myelodysplastic
syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk
acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or
radiation therapy, which is intended to kill cancer cells that may be resistant to more
standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the
bone marrow, including stem cells. After the treatment, patients must have a healthy supply
of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood
cell production process in the bone marrow. The healthy stem cells may come from the blood or
bone marrow of a related or unrelated donor. If patients do not have a matched related donor,
doctors do not know what the next best donor choice is. This trial may help researchers
understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS
is better or if there is no difference at all.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05457556
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Heather J Symons
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05457556