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New drug combo aims to speed immune recovery after stem cell transplant

NCT ID NCT01746849

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

82 people

The number who actually took part.

Start date

Dec 2012

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

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

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

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.