Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00691015
• Date of registration: 04/06/2008
• Primary sponsor: Barbara Ann Karmanos Cancer Institute
• Public title: Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
• Scientific title: A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
• Date of first enrolment: May 2008
• Target sample size: 48
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00691015
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Zaid Al-Kadhimi, MD
• Affiliation: Barbara Ann Karmanos Cancer Institute

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Diagnosis of a hematological malignancy, including any of the following:

- Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)

- Hodgkin lymphoma in CR or PR

- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting
either of the following criteria:

- In CR

- Not in CR and meets the following criteria:

- Bone marrow blast < 20% within 4 weeks of transplantation

- Peripheral blood absolute blast count < 500 per microliter on the day
of initiating conditioning therapy

- Myelodysplastic syndromes, treated or untreated

- Chronic myeloid leukemia in chronic phase or accelerated phase

- Multiple myeloma in CR or PR

- Chronic lymphocytic leukemia in second or greater CR or PR

- Myelofibrosis or other myeloproliferative disorders meeting the following
criteria:

- Bone marrow blasts < 20% within 4 weeks of transplantation

- Peripheral blood absolute blast count < 500 per microliter on the day of
initiating conditioning therapy

- Patients with ascites not allowed

- No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+
enrichment, T-cell depletion, etc)

- Scheduled to undergo peripheral blood stem cell transplantation from a suitable
HLA-matched or -mismatched unrelated donor, as determined by treating physician

- High resolution molecular HLA typing is required for HLA class I and II

- No more than one antigen or allele mismatch

- No documented uncontrolled CNS disease

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2

- Karnofsky PS 60-100%

- Creatinine clearance > 50 mL/min

- Bilirubin < 3 times upper limit of normal (ULN)

- ALT and AST < 3 times ULN

- LVEF > 50%

- FVC, FEV_1, or DLCO > 50% predicted

- Patients on home oxygen not allowed

- Able to cooperate with oral medication intake

- HIV negative

- No active hepatitis B or hepatitis C

- No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Myeloproliferative Disorders

Leukemia

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasms

Intervention(s)

Biological: rituximab

Drug: busulfan

Drug: carmustine

Drug: cyclophosphamide

Drug: cytarabine

Drug: etoposide

Drug: fludarabine phosphate

Drug: melphalan

Radiation: total-body irradiation

Primary Outcome(s)

Incidence and severity of acute graft-versus-host disease (GVHD) [Time Frame: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria]

Safety, as defined by serious adverse events and adverse events related to study treatment. [Time Frame: Within 6 months after PBSCT]

Secondary Outcome(s)

Biomarkers and immunocorrelative studies (i.e., T-cell, B-cell, NK-cell, regulatory T-cell, and allo-reactive T-cell quantitation studies by flow cytometry) [Time Frame: At 30, 60, 90, and 180 days after PBSCT]

Incidence of chronic GVHD. [Time Frame: Within 2 years after PBSCT]

Incidence of infections, including bacterial, fungal, and viral infections (i.e., CMV and EBV reactivation, including post-transplant lymphoproliferative disorders) [Time Frame: Within 6 months after PBSCT]

Incidence of thrombotic microangiopathy [Time Frame: Within 100 days after PBSCT]

Karnofsky performance status [Time Frame: At baseline and at 100 days, 6 months, 1 year, and 2 years after PBSCT]

Length of hospital stay. [Time Frame: Within 100 days after PBSCT]

Overall and disease-free survival. [Time Frame: At 2 years after PBSCT]

Time to engraftment (i.e., absolute neutrophil recovery [ANC > 1,500/mm³] and platelet recovery [platelet count > 25,000/mm³]) [Time Frame: At screening, post transplant, 30, 60, 90 & 180 days after PBSCT]

Secondary ID(s)

CDR0000597130

GENZ-WSU-2007-127

P30CA022453

WSU-2007-127

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)