Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00185640
First received: September 12, 2005
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.


Condition Intervention Phase
Blood Cancer
Leukemia
Drug: cyclosporine
Drug: Thymoglobulin
Drug: mycophenolate mofetil
Drug: g-csf
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the incidence and extent of chronic GVHD. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
  • To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
  • To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
  • To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism. [ Time Frame: Unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2003
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-myeloablative transplantation Drug: cyclosporine
3-5 mg/kg BID; IV or oral
Other Names:
  • cyclosporin
  • cyclosporin A
Drug: Thymoglobulin
7.5-10 mg/kg; IV
Other Name: Anti-thymocyte globulin
Drug: mycophenolate mofetil
15 mg/kg BID or Q 8 hours
Other Names:
  • MMF
  • CellCept
Drug: g-csf
16 mcg/kg; SQ
Other Names:
  • Granulocyte colony-stimulating factor
  • gcsf
  • colony-stimulating factor 3
  • csf 3

  Eligibility

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

Inclusion Criteria:

(A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.

(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.

(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.

(D) Patient must be competent to give consent.

Exclusion Criteria:

(A) Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.

(B) Uncontrolled CNS involvement with disease

(C) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment

(D) Females who are pregnant

(E) Organ dysfunction defined as follows:

  • Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
  • Pulmonary: DLCO <40% predicted
  • Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
  • Renal: creatinine clearance <50 cc/min (24 hour urine collection)

(F) Karnofsky performance score < 60%

(G) Patients with poorly controlled hypertension on multiple antihypertensives

(H) Documented fungal disease that is progressive despite treatment

(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis

(J) Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185640

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert Lowsky Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00185640     History of Changes
Obsolete Identifiers: NCT00186615
Other Study ID Numbers: BMT153, 78998, BMT153, 11960
Study First Received: September 12, 2005
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Hematologic Diseases
Antilymphocyte Serum
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Lenograstim
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 10, 2014