Clinical trial · Interventional
Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): subject accrual and data analysis is completed.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood, and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation followed by sargramostim in treating patients who have chronic myelogenous leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| in vitro-treated bone marrow transplantation | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of chronic myelogenous leukemia (CML) documented by cytogenetic and molecular analyses at Johns Hopkins
* Philadelphia chromosome (Ph)-positive or -negative CML
* Ph-negative CML allowed with presence of either:
* BCR-ABL rearrangement (on molecular, fluorescent in situ hybridization, or polymerase chain reaction analyses)
* p210 protein
* One of the following:
* Patient age 18 to 65
* Disease duration longer than 3 years
* Accelerated phase CML
* Accelerated phase diagnosis based on any of the following:
* More than 10% to less than 30% blasts in blood or bone marrow
* No hematologic response to prior conventional therapy (hydroxyurea or interferon)
* Extramedullary disease (e.g., progressive splenomegaly or lymphadenopathy)
* Basophilia greater than 10% in blood or bone marrow
* Other cytogenetic abnormalities in addition to a single Ph chromosome
* Second chronic phase
* Failure on interferon suggested of patients over age 18 with chronic phase CML, with failure defined as:
* No detectable Ph-negative metaphases in marrow after 6 months
* No progressive increase in Ph-negative metaphases in marrow after 6-12 months
* Less than 50% Ph-negative metaphases after 1 year
* No complete cytogenetic remission after 2 years
* Intolerance to interferon therapy
* No blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML
* The following conditions are allowed:
* Leukocyte count abnormalities
* Fibrosis
* Anemia
* Fever or bone pain
* Thrombocytopenia
* Bone marrow reticulin
* Availability of an HLA-identical sibling donor
* At least 3 years of age (priority given to donors over age 10)
* Priority given to CMV-negative donor if patient CMV-negative
* No medical or psychiatric condition that precludes transplant procedure
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Not specified
Renal
* Not specified
Other
* No history of intolerance to sargramostim (GM-CSF)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
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