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

This study has been completed.

First Received on October 30, 2002. Last Updated on April 9, 2007 History of Changes

Sponsor:	Baylor College of Medicine
Collaborators:	The Methodist Hospital System Texas Children's Hospital Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00048412

Purpose

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.

Condition	Intervention	Phase
Myelodysplastic Disorders Leukemia Multiple Myeloma Plasma Cell Dyscrasia Lymphoproliferative Disorders	Drug: FLUDARABINE Drug: CAMPATH 1H Drug: FK50 Procedure: Stem Cell Collection and Infusion	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia Multiple Myeloma

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment:	40
Study Start Date:	June 2000

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)

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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):
1. Greater to or equal to 50 years of age.
2. EF of less than 45%
3. DLCO less than 50% of FEV1 50-75% of predicted value.
4. Diabetes Mellitus
5. Renal Insufficiency (but creatine clearance not less than 25ml/min).
6. Prior recent history of systemic fungal infection.
7. 3rd or greater remission of AML or ALL
8. More than 1 year of diagnosis (CML or Myeloma patients)
9. Multiple types of treatment regimens. (equal to or more than 3)
10. Prior autologous or allogeneic stem cell transplantation.
11. Significant grade III or IV neurologic or hepatic toxicity from previous treatment.
12. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048412

Locations

United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

The Methodist Hospital System

Texas Children's Hospital

Center for Cell and Gene Therapy, Baylor College of Medicine

Investigators

Principal Investigator:

George Carrum, MD

Baylor College of Medicine

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00048412 History of Changes
Other Study ID Numbers:	H8714, DIMSUM
Study First Received:	October 30, 2002
Last Updated:	April 9, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Leukemia
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases

Hemorrhagic Disorders
Fludarabine
Fludarabine monophosphate
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012