Loading clinical trials...

COMPLETEDPHASE1/PHASE2

Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)

Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia

NCT00167219•Masonic Cancer Center, University of Minnesota

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.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Exclusion Criteria

•Active uncontrolled infection within one week of HCT.

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

November 18, 1999

Primary Completion Date

July 12, 2022

Completion Date

August 9, 2023

Last Updated

November 7, 2023

Enrollment

ACTUAL participants

Conditions

Juvenile Myelomonocytic Leukemia

Interventions

Stem Cell Transplant

BIOLOGICAL

Preparative Regimen

DRUG

A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy

NCT06247787

Recurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Myelodysplastic Syndrome+4 more

View study

RECRUITINGPHASE1/PHASE2

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

NCT04726241

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia+6 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)

Inclusion Criteria

Exclusion Criteria

A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases

Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation