TriangleNCT00167219 · REGISTRY CONDITION SEARCH
Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2023-11-07
The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML): * Leukocytosis (\> 13,000) with absolute monocytosis (\> 1,000) * The presence of immature myeloid cells in the peripheral blood * Less than 30% marrow blasts * Absence of t(9:22) or BCR-ABL transcript * Adequate major organ function including: * Cardiac: ejection fraction \> 45% * Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites) * Karnofsky performance status \> 70% or Lansky score \> 50% * Creatinine must be \< 2 x normal for age * Written informed consent. Exclusion Criteria: * Active uncontrolled infection within one week of HCT.
- healthy Volunteers
- false
- maximum Age
- 18 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receiving study regimen.
- intervention Names
- Biological: Stem Cell Transplant
- Drug: Preparative Regimen
- label
- Intent-to-Treat
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Intent-to-Treat
- description
- Transplantation on Day 0.
- name
- Stem Cell Transplant
- other Names
- Bone marrow transplantation
- type
- BIOLOGICAL
- arm Group Labels
- Intent-to-Treat
- description
- * Busulfan * Cyclophosphamide * Mesna * Melphalan * Anti-thymocyte Globulin (ATG)
- name
- Preparative Regimen
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 15
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Determine Probability of Long-term Disease Free Survival in JMML
- time Frame
- at 1 year after transplant
- secondary Outcomes
- description
- Measured by AGVHD Grades 2 - 4.
- measure
- Combined Incidence of Neutrophil Engraftment, Graft-versus-host Disease (GVHD), Regimen-related Toxicity, and Relapse.
- time Frame
- at 1 year after transplant
Full study description
- brief Summary
- The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).
- detailed Description
- Prior to transplantation, subjects will receive BUSULFAN via the central venous line, six times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's leukemia. As well, these drugs will destroy the subject's own immune system to help ensure the new bone marrow takes and grows after transplantation. On the day of transplantation, bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line. These new cells will replace the subject's bone marrow.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
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- occurrences
- context exact
- NCT00167219
- end
- 11
- exact text
- NCT00167219
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Juvenile Myelomonocytic Leukemia
- query disease state id
- ds-juvenile-myelomonocytic-leukemia
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
- source file sha256
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- source json pointer
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- source kind
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- source record id
- Source null
- source string basis
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- source string sha256
- 72aae93f7837f7421b951021016463ceec8b2ea1dc8be0c93509869ab5037dbc
Preserved source evidence · Not medical advice