Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Phase 2

Completed

• Conditions: MDS; AML; APLASTIC ANEMIA; MULTIPLE MYELOMA; MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET); ALL; RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA; CML Chronic Phase, Accelerated Phase, or Blast Crisis; CLL
• Interventions: Drug: Cyclophosphamide; Drug: fludarabine; Drug: cyclosporine; Drug: methotrexate; Biological: G-CSF

• Registration Number: NCT00636909
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-07
• Primary Completion: 2006-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-17
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	G-CSF	Study treatment arm with G-CSF
1	Cyclophosphamide	Study treatment arm with G-CSF
1	fludarabine	Study treatment arm with G-CSF
1	cyclosporine	Study treatment arm with G-CSF
1	methotrexate	Study treatment arm with G-CSF

Primary Outcome Measures

Name	Time	Method
durable engraftment	100 days
hematopoeitic reconstitution	3 years
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells	3 years

Secondary Outcome Measures

Name	Time	Method
disease free survival and overall survival	3 years
incidence of treatment related toxicity and acute and chronic graft versus host disease	100 days