Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

MULTIPLE MYELOMA Clinical Trial

— MINI HEME  

Official title:

Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636909
• Other study ID #: 2001P002293
• Secondary ID: W-99-0234-FB
• Status: Completed
• Phase: Phase 2
• First received: March 10, 2008
• Last updated: April 5, 2017
• Start date: July 1999

Study information

• Verified date: April 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria - Patient:

• AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET

• Age less than 65 years

• Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses

• Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol

Inclusion Criteria - Donor:

• Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells

• Absence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest

• Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C

• The donor must be blood relation. A prospective related donor must be at least genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.

Exclusion Criteria - Patient:

• Active CNS involvement

• Females who are pregnant or breast feeding

• ECOG performance status > 1. Karnofsky performance status < 80%

• LVEF < 40%

• Active viral, bacterial, or fungal infection

• Patients seropositive for HIV; HTLV -1

• Patients not providing informed consent

• Patients with known hypersensitivity to E. Coli derived product

Exclusion Criteria - Donor:

• A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral hepatitis infection. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Donors with known hypersensitivity to E. Coli derived products.

Related Conditions & MeSH terms

• ALL
• AML
• Anemia, Aplastic
• APLASTIC ANEMIA
• Blast Crisis
• CLL
• CML Chronic Phase, Accelerated Phase, or Blast Crisis
• Disease
• Hematologic Diseases
• Hodgkin Disease
• MDS
• MULTIPLE MYELOMA
• MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA

Intervention

Drug:
• Cyclophosphamide
preparative cytoreduction
• fludarabine
preparative cytoreduction
• cyclosporine
immunosuppressive therapy
• methotrexate
immunosuppressive therapy

Biological:
• G-CSF
foster engraftment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	durable engraftment		100 days
Primary	hematopoeitic reconstitution		3 years
Primary	evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells		3 years
Secondary	disease free survival and overall survival		3 years
Secondary	incidence of treatment related toxicity and acute and chronic graft versus host disease		100 days