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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00167219
Other study ID # 1999LS073
Secondary ID MT1999-209911M24
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 18, 1999
Est. completion date August 9, 2023

Study information

Verified date November 2023
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Other known NCT identifiers
  • NCT00262756

Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 9, 2023
Est. primary completion date July 12, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Stem Cell Transplant
Transplantation on Day 0.
Drug:
Preparative Regimen
Busulfan Cyclophosphamide Mesna Melphalan Anti-thymocyte Globulin (ATG)

Locations

Country Name City State
United States Masonic Cancer Center, University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine Probability of Long-term Disease Free Survival in JMML at 1 year after transplant
Secondary Combined Incidence of Neutrophil Engraftment, Graft-versus-host Disease (GVHD), Regimen-related Toxicity, and Relapse. Measured by AGVHD Grades 2 - 4. at 1 year after transplant
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