Trial intelligence / Profile preview

Non-Ablative Conditioning for Allogeneic Stem Cell Transplant

NCT00008307Phase 2

Key facts

Status
Unknown
Start
Apr 1998
Countries
1
Sponsor
Herbert Irving Comprehensive Cancer Center
Modality
Orthosteric Ligands, Metabolically Activated Prodrugs
Conditions
leukemialymphomamultiple myeloma (MM)myelodysplastic syndrome (MDS)aplastic anemia
01

Overview

Phase 2, open-label, single-arm trial of fludarabine and melphalan in leukemia, lymphoma, multiple myeloma (MM) and 5 more, sponsored by Herbert Irving Comprehensive Cancer Center. Primary endpoints: Hematopoietic recovery and Incidence of graft-versus-host disease. Status: unknown.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Non-Ablative Conditioning

    Fludarabine + Melphalan followed by Allogeneic SCT

03

Who it enrols

Patients with confirmed hematologic malignancy (CML, AML, ALL, MDS, Lymphoma, MM) or genetic disorder (e.g., storage disease, hemoglobinopathy, immunodeficiency) who are unwilling or unable to undergo conventional high-dose conditioning. Must have a suitable donor.

04

Endpoints

Primary

  • Hematopoietic recovery

  • Incidence of graft-versus-host disease

Secondary

  • Chemotherapeutic toxicity

  • Relapse

  • Survival

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