search
Back to results

Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

Primary Purpose

Myelodysplastic Disorders, Leukemia, Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FLUDARABINE
CAMPATH 1H
FK50
Stem Cell Collection and Infusion
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Disorders

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma. Conditions that increase treatment related mortality (need one or more to be eligible): Greater to or equal to 50 years of age. EF of less than 45% DLCO less than 50% of FEV1 50-75% of predicted value. Diabetes Mellitus Renal Insufficiency (but creatine clearance not less than 25ml/min). Prior recent history of systemic fungal infection. 3rd or greater remission of AML or ALL More than 1 year of diagnosis (CML or Myeloma patients) Multiple types of treatment regimens. (equal to or more than 3) Prior autologous or allogeneic stem cell transplantation. Significant grade III or IV neurologic or hepatic toxicity from previous treatment. No matched sibling donor. Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1) Patient and/or responsible person able to understand consent. Age between birth and 70 years. For women of childbearing potential, negative pregnancy test. Exclusion criteria Patient is pregnant, lactating or unwilling to use contraceptives HIV positive patient Uncontrolled intercurrent infection Refractory AML, or ALL Untreated Blast Crisis for CML Uncontrolled High-grade lymphoproliferative disease/lymphoma. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater) Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater) Hemodialysis dependent Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months) Active CNS disease from hematological disorder.

Sites / Locations

  • Texas Children's Hospital
  • The Methodist Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 30, 2002
Last Updated
January 15, 2020
Sponsor
Baylor College of Medicine
Collaborators
The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00048412
Brief Title
Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H
Official Title
Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
November 12, 2004 (Actual)
Study Completion Date
November 12, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine

4. Oversight

5. Study Description

Brief Summary
To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.
Detailed Description
This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments. The following will be given to the patient after admission: Day - 6: Total body irradiation Day - 5 to - 2: Fludarabine and Campath 1H Day - 1: Day of rest Day 0: Stem cell transplant (infusion)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Disorders, Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FLUDARABINE
Intervention Type
Drug
Intervention Name(s)
CAMPATH 1H
Intervention Type
Drug
Intervention Name(s)
FK50
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Collection and Infusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma. Conditions that increase treatment related mortality (need one or more to be eligible): Greater to or equal to 50 years of age. EF of less than 45% DLCO less than 50% of FEV1 50-75% of predicted value. Diabetes Mellitus Renal Insufficiency (but creatine clearance not less than 25ml/min). Prior recent history of systemic fungal infection. 3rd or greater remission of AML or ALL More than 1 year of diagnosis (CML or Myeloma patients) Multiple types of treatment regimens. (equal to or more than 3) Prior autologous or allogeneic stem cell transplantation. Significant grade III or IV neurologic or hepatic toxicity from previous treatment. No matched sibling donor. Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1) Patient and/or responsible person able to understand consent. Age between birth and 70 years. For women of childbearing potential, negative pregnancy test. Exclusion criteria Patient is pregnant, lactating or unwilling to use contraceptives HIV positive patient Uncontrolled intercurrent infection Refractory AML, or ALL Untreated Blast Crisis for CML Uncontrolled High-grade lymphoproliferative disease/lymphoma. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater) Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater) Hemodialysis dependent Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months) Active CNS disease from hematological disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Carrum, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

We'll reach out to this number within 24 hrs