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Acute LeukemiaPhase 2NCT03970096

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

A Phase 2 study testing Total-Body Irradiation, Thiotepa and Fludarabine in people with Acute Leukemia and Acute Lymphoblastic Leukemia, run by Fred Hutchinson Cancer Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone… Read more about this study

Who is it for?
Ages 1 year to 60 years
What is being tested?
Total-Body Irradiation, Thiotepa and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
19 Nov 2019to 31 Dec 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:
  • Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (< 5% marrow blasts by morphology).
  • Acute myeloid leukemia (AML) in first or subsequent morphological remission (< 5% marrow blasts by morphology).
  • Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia, chronic myeloid leukemia [CML] with blast crisis or other chronic myeloproliferative neoplasm) in first or subsequent morphological remission (<5% marrow blasts by morphology).
  • Myelodysplastic syndrome (MDS) with a history of excess blasts (≥ approximately 5% in marrow blasts by morphology) and a history of receiving cytoreductive therapy (including but not limited to BCL-2 inhibitors or cytotoxic chemotherapy) within the past 3 months.
  • Patient age 1-60 years old (inclusive) at the time of informed consent
Show all 19Show fewer
  • Patients aged 1-50 years old (inclusive) are eligible for TBI-based conditioning regimens.
  • Patients aged 1-60 years old (inclusive) are eligible for busulfan-based conditioning regimens (with or without TBI 4 Gy).
  • Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 matched) related or unrelated donor capable of donating PBSC.
  • Recipient informed consent/assent and/or legal guardian permission must be obtained.
  • DONOR: HLA-matched related and unrelated donors (HLA-A, B, C, DRB1 and DQB1 matched based on high-resolution typing).
  • DONOR: >= 18 years old.
  • DONOR: Willing to donate PBSC.
  • DONOR: Matched related donors:
  • Must give informed consent using the related donor informed consent form.
  • Must meet institutional donor eligibility criteria or be ineligible with statement that the donor is a first or second degree relative (exception 21 Code of Federal Regulations [CFR] 1271.65(b)(i)).
  • DONOR: Matched unrelated donors:
  • Must consent according to the applicable National Marrow Donor Program (NMDP) donor regulatory requirements.
  • Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii)).

Who cannot join

  • Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation. A patient may have a history of CNS disease. However, any CNS disease must be cleared by the end of the pre-conditioning evaluation time frame. If CNS disease is identified on cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.
  • Patients on other experimental protocols for prevention of GVHD.
  • Patient weight:
  • Patients with HLA-matched related donors will be excluded if they weigh >= 110 kg.
  • Patients with HLA-matched unrelated donors will be excluded if they weigh >= 110 kg and must be discussed with the Fred Hutch protocol principal investigator (PI) if they weigh >= 90 kg.
  • Patients who are positive for human immunodeficiency virus (HIV)-1, HIV-2, human T-cell lymphotropic virus (HTLV)1 or HTLV2.
Show all 21Show fewer
  • Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician; i.e. patients with active infections require infectious disease consultation and documentation by the infectious disease team that myeloablative HCT is not considered to be contraindicated. Upper respiratory tract infection is not considered to represent an uncontrolled infection in this context.
  • Patients with organ dysfunction, including:
  • Renal insufficiency (creatinine > 1.5 mg/dl) at the time of evaluation for the protocol. Patients with a known history of creatinine > 1.5 mg/dl or a current serum creatinine above the normal range for age must have a current creatinine clearance of > 60 ml/min/1.73 m^2 (measured by 24-hr urine specimen or nuclear glomerular filtration rate [GFR]).
  • Left ventricular ejection fraction < 45%.
  • Carbon monoxide diffusing capability (DLCO) corrected < 60%. Patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is < 92% on room air.
  • Liver function abnormality. Patients who have liver function test (LFT)s (specifically, total bilirubin, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, MTX, trimethoprim-sulfamethoxazole, or another drug). If the GI physician considers that HCT on the protocol is contraindicated, that patient will be excluded from the protocol. Patients with Gilbert's syndrome require GI physician consultation but may be included on the protocol. Patients with no other known liver function abnormality or with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol.
  • Patients who have received previous myeloablative allogeneic or autologous transplantation.
  • Patients with a life expectancy < 12 months from co-existing disease other than the leukemia or MDS.
  • Patients who are pregnant or breast-feeding.
  • Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT.
  • Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.
  • Patients with a known hypersensitivity to tacrolimus or MTX
  • Patients who have received checkpoint inhibitors within three months of transplantation unless an exception is made by the PI
  • DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection. Test must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits (serological and/or nucleic acid amplification test [NAT] and/or other approved testing) in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory.
  • Unrelated donors donating outside of the USA.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie Bleakley contact

206-667-6572

mbleakle@fredhutch.org

United States3 sites, 3 recruiting

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

    Alison Sehgal, 412-623-2861, sehgalar@upmc.edu

    Alison Sehgal

    Recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Marie Bleakley, 206-667-6572, mbleakle@fredhutch.org

    Marie Bleakley

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Taiga Nishihori, 813-745-4673, taiga.nishihori@moffitt.org

    Taiga Nishihori

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Read the detailed description

OUTLINE: Patients are randomized to 1 of 2 arms (Arms A and C).

ARM A: Patients are assigned to 1 of 2 arms.

ARM A1 (TBI BASED): Patients undergo total-body irradiation (TBI) twice daily (BID) on days -10 to -7, and receive thiotepa intravenously (IV) over 3 hours on days -6 and -5, fludarabine IV over 30 to 60 minutes on days -6 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid).

ARM A2 (BUSULFAN BASED): Patients receive fludarabine IV over 30 to 60 minutes on days -6 to -2, busulfan IV over 180 minutes on days -5 to -2, and undergo TBI BID on day -1. Patients also receive tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid).

ARM C: Patients are assigned to 1 of 2 arms.

ARM C1: Patients undergo TBI BID on days -4 to -2 or -3 to -1, and receive PBSC IV on day 0. Patients also receive cyclophosphamide IV over 1 to 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5 approximately 24 hours after the end of the second dose of cyclophosphamide. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid).

ARM C2: Patients receive fludarabine IV over 30 to 60 minutes on days -5 to -2, busulfan IV over 180 minutes on days -5 to -2, PBSC IV on day 0, cyclophosphamide IV over 1 to 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5 approximately 24 hours after the end of the second dose of cyclophosphamide. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid).

ARM D: (DISCONTINUED NOVEMBER 2021): Patients are assigned to 1 of 2 arms.

ARM D1: Patients undergo TBI BID on days -6 to -4, and receive cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid).

ARM D2: Patients receive busulfan IV over 180 minutes on days -8 to -5, cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid).

All patients also undergo bone marrow aspiration/biopsy, echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at days 7, 14, 21, 28, 56, 80, 180, and 270 and at 1, 1.5, and 2 years.

Being tested
Total-Body Irradiation, Thiotepa, Fludarabine, Tacrolimus, Allogeneic CD34+-enriched and CD45RA-depleted PBSCs
Keywords
Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Other Hematopoietic
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Lymphoid, Leukemia, Monocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total-Body IrradiationRadiation

    Also called Total Body Irradiation, Whole-Body Irradiation, TBI, Whole Body Irradiation

    Undergo TBI

  • ThiotepaDrug

    Also called Oncotiotepa, STEPA, Tepadina, TESPA

    Given IV

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • TacrolimusDrug

    Also called Prograf, Protopic, FK-506

    Given IV

  • Allogeneic CD34+-enriched and CD45RA-depleted PBSCsBiological

    Also called Allogeneic TN-depleted CD34-preserved PBSCs, Allogeneic TND- CD34+ PBSCs, Donor-derived TN Cell Depleted CD34-enriched PBSCs, Naive T-cell Depleted CD34+ Allogeneic Peripheral Blood Stem Cells

    Given IV

  • MethotrexateDrug

    Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate

    Given IV

  • CyclophosphamideDrug

    Also called Ciclofosfamida, Ciclofosfamide, Cicloxal, Claphene

    Given IV

  • Peripheral Blood Stem CellBiological

    Also called PBSC, Peripheral Blood Stem Cells, peripheral stem cell, Peripheral Stem Cells

    Given IV

  • CyclosporineDrug

    Also called Ciclosporin, CsA, Cyclosporin, Cyclosporin A

    Given IV

  • SirolimusDrug

    Also called RAPA, Rapamune, rapamycin, SILA 9268A

    Given IV

  • BusulfanDrug

    Also called Bussulfam, Busulfanum, Busulphan, Busulfex

    Given IV

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow aspiration/biopsy

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

Study groups in NCT03970096
Study groupRoleWhat they receive
Arm A1 (TBI, TnD)ExperimentalPatients undergo TBI BID on days -10 to -7, and receive thiotepa IV over 3 hours on days -6 and -5, fludarabine IV over 30 to 60 minutes on days -6 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.
Receives: Radiation: Total-Body Irradiation; Drug: Thiotepa; Drug: Fludarabine; Drug: Tacrolimus; Biological: Allogeneic CD34+-enriched and CD45RA-depleted PBSCs; Drug: Methotrexate; Drug: Cyclosporine; Drug: Sirolimus; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection
Arm A2 (busulfan, TnD)ExperimentalPatients receive fludarabine IV over 30 to 60 minutes on days -6 to -2, busulfan IV over 180 minutes on days -5 to -2, and undergo TBI BID on day -1. Patients also receive tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.
Receives: Drug: Fludarabine; Drug: Tacrolimus; Biological: Allogeneic CD34+-enriched and CD45RA-depleted PBSCs; Drug: Methotrexate; Drug: Cyclosporine; Drug: Sirolimus; Drug: Busulfan; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection
Arm C1 (TBI, PTCy, tacrolimus)ExperimentalPatients undergo TBI BID on days -4 to -2 or -3 to -1, and receive PBSC IV on day 0. Patients also receive cyclophosphamide IV over 1 to 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.
Receives: Radiation: Total-Body Irradiation; Drug: Tacrolimus; Drug: Cyclophosphamide; Biological: Peripheral Blood Stem Cell; Drug: Cyclosporine; Drug: Sirolimus; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection
Arm C2 (busulfan, PTCy, tacrolimus)ExperimentalPatients receive fludarabine IV over 30 to 60 minutes on days -5 to -2, busulfan IV over 180 minutes on days -5 to -2, PBSC IV on day 0, cyclophosphamide IV over 1 to 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.
Receives: Drug: Fludarabine; Drug: Tacrolimus; Drug: Cyclophosphamide; Biological: Peripheral Blood Stem Cell; Drug: Cyclosporine; Drug: Sirolimus; Drug: Busulfan; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection
Arm D1 (TBI, tacrolimus, methotrexate) [DISCONTINUED NOVEMBER 2021]ExperimentalPatients undergo TBI BID on days -6 to -4, and receive cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.
Receives: Radiation: Total-Body Irradiation; Drug: Tacrolimus; Drug: Methotrexate; Drug: Cyclophosphamide; Biological: Peripheral Blood Stem Cell; Drug: Cyclosporine; Drug: Sirolimus; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection
Arm D2 (busulfan, tacrolimus, methotrexate) [DISCONTINUED NOVEMBER 2021]ExperimentalPatients receive busulfan IV over 180 minutes on days -8 to -5, cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.
Receives: Drug: Tacrolimus; Drug: Methotrexate; Drug: Cyclophosphamide; Biological: Peripheral Blood Stem Cell; Drug: Cyclosporine; Drug: Sirolimus; Drug: Busulfan; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Graft versus host disease (GVHD)-free relapse-free survival (RFS)

    Will be defined as survival-free of a history of: a) relapse after hematopoietic cell transplantation (HCT), b) grade III-IV acute GVHD after HCT, moderate or severe chronic GVHD meeting National Institutes of Health (NIH) criteria and requiring systemic pharmacologic immunosuppression for treatment of GVHD. RFS distribution will be estimated for each arm by the Kaplan-Meier curve, starting from the time of HCT. A 90% confidence interval (CI) will be constructed at 1 and 2-year post-HCT timepoints.

    Measured: At 2 years

Secondary outcomes (5)

  1. Overall survival (OS)

    Death will be considered as the event, and the OS distribution will be estimated for each group by the Kaplan-Meier method, starting from the time of HCT. A 90% CI will be constructed at the 1 and 2-year post-HCT time points.

    Measured: At 2 years

  2. Relapse

    Will be defined as recurrence of leukemia (>= 5% leukemic blasts by flow or morphology) in bone marrow, circulating leukemic blasts or extramedullary disease (extramedullary disease definite i.e. proven by biopsy or probably based on clinical assessment if biopsy not feasible). Lower levels of leukemia in bone marrow or blood will be recorded and reported as 'measurable residual disease' but will not be considered relapse.

    Measured: At 2 years

  3. Proportion of patients alive and off prednisone (or equivalent systemic corticosteroid) for treatment of GVHD

    Measured: At 3, 6, 9, 12, 15, 18, 21, 24 months post HCT

  4. Graft rejection or irreversible graft failure (> 14 days duration)

    Will be operationally defined as failure to achieve an absolute neutrophil count (ANC) >= 0.5 x 10^9/L before death or second HCT, or decrease to ANC < 0.1 x 10^9/L for 14 consecutive days (date of graft failure defined as the 14th day) after an established donor graft despite daily administration of granulocyte colony-stimulating factor (subcutaneously or intravenously) and =< 20% bone marrow cellularity on bone marrow aspirate or biopsy any time in the first 2 years following HCT. If the delay or reduction in ANC is due to relapse (as determined by histopathology, flow cytometry or cytogenetic or molecular studies) this will not be considered graft failure. If a patient dies from organ toxicity and/or infection prior to day 28 without ANC >= 0.5 x 10^9/L this will not be considered graft failure.

    Measured: At 2 years

  5. Incidence of chronic GVHD

    Will be defined and graded based on NIH criteria and graded operationally as the occurrence of compatible symptoms.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start19 Nov 2019
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970096
Sponsor's protocol ID
RG1005364
Other IDs
9749, NCI-2019-03188, P30CA015704, P01CA018029
Status last verified
Oct 2026
First submitted
29 May 2019
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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