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

NCT ID: NCT00048412

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2004-11-12

Brief Summary

1. 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.

2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.

3. 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)

Conditions

Myelodysplastic Disorders; Leukemia; Multiple Myeloma; Plasma Cell Dyscrasia; Lymphoproliferative Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

FLUDARABINE

Intervention Type: DRUG

CAMPATH 1H

Intervention Type: DRUG

FK50

Intervention Type: DRUG

Stem Cell Collection and Infusion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. 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)

4. Patient and/or responsible person able to understand consent.

5. Age between birth and 70 years.

6. For women of childbearing potential, negative pregnancy test.

Exclusion Criteria

1. Patient is pregnant, lactating or unwilling to use contraceptives

2. HIV positive patient

3. Uncontrolled intercurrent infection

4. Refractory AML, or ALL

5. Untreated Blast Crisis for CML

6. Uncontrolled High-grade lymphoproliferative disease/lymphoma.

7. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

8. Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)

9. Hemodialysis dependent

10. Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.

11. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)

12. Active CNS disease from hematological disorder.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

George Carrum

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Carrum, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

DIMSUM

Identifier Type: -

Identifier Source: secondary_id

H8714

Identifier Type: -

Identifier Source: org_study_id