New drug combo aims to speed immune recovery after stem cell transplant
NCT ID NCT01746849
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving palifermin and leuprolide acetate can help the immune system recover more quickly after a stem cell transplant for blood cancers like leukemia and lymphoma. About 82 participants will receive these drugs alongside their transplant. The goal is to see if this approach leads to a faster return of infection-fighting cells.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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82 people
The number who actually took part.
- Start date
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Dec 2012
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Treatment Portion: * AML in 1st remission - for patients whose AML does not have "good risk" cytogenetic features (i.e. t (8;21), t(15;17), inv 16 without c-kit mutations). * Acute leukemias of ambiguous lineage in ≥ 1st remission * Secondary AML in remission * AML in ≥ 2nd remission * ALL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL ≥ 2nd remission * CML failing to respond to or not tolerating imatinib, dasatinib or nilotinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis. * Non-Hodgkins lymphoma with chemo responsive disease in any of the following categories: intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants. b.ii. any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant. * Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2 * Chronic myelomonocytic leukemia: CMML-1 and CMML-2. * Patient's age is ≥18 or ≤60 years old * Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status ≥ 70% * Patients must have adequate organ function measured by: Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50% and must improve with exercise. * Pulmonary: asymptomatic or if symptomatic, DLCO \> 60% of predicted (corrected for hemoglobin) * Hepatic: \< 3xULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia * Renal: serum creatinine \< 1.2 mg/dL or if serum creatinine is outside the normal range, the CrCl \> 50 ml/min (measured or calculated/estimated) * Patients have a plan to receive a CD34-selected peripheral blood stem cell transplant with TBI-based conditioning. Exclusion Criteria: * Active extramedullary disease * Active and uncontrolled infection at time of transplantation * Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months. * Pregnant or breast feeding * HIV infection * Patient is felt to not be a candidate for TBI by the BMT service Donor Inclusion Criteria: * Donor must be willing and able to undergo PBSC collection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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