Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01118013
• Date of registration: 05/05/2010
• Primary sponsor: Cancer and Leukemia Group B
• Public title: Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
• Scientific title: Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation
• Date of first enrolment: December 2010
• Target sample size: 88
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01118013
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Asad Bashey, MD, PhD
• Affiliation: Blood and Marrow Transplant Group of Georgia

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed hematologic malignancies:

- Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)

- Absolute lymphocytosis of > 5,000/µL

- Lymphocytes must appear morphologically mature with < 55% prolymphocytes
(CLL)

- Patients with > 55% prolymphocytes are considered as having PLL

- Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)

- Non-Hodgkin lymphoma

- Any WHO classification of histologic subtype

- Core biopsies acceptable for primary diagnosis and immunophenotyping

- Bone marrow biopsies as sole means of diagnosis not allowed for follicular
lymphoma

- Hodgkin lymphoma

- Any WHO classification of histologic subtype

- Core biopsies acceptable for primary diagnosis and immunophenotyping

- Bone marrow biopsy is required

- Multiple myeloma

- Patients must have active disease requiring treatment (Durie-Salmon stage
I-III)

- Acute myeloid leukemia

- Must have < 10% bone marrow blasts and no circulating blasts

- Myelodysplastic syndrome (MDS)

- MDS as define by WHO criteria

- Must have < 10% marrow blasts

- Relapsed or progressive disease or myelodysplasia = 6 months after prior high-dose
chemotherapy with autologous hematopoietic cell support

- Prior syngeneic transplantation allowed

- Healthy donor meeting one of the following criteria:

- HLA-identical sibling (6/6)

- Serologic typing for class I (A, B) and molecular typing for class II
(DRB1) required

- 8/8 matched-unrelated donor

- Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing
required

- No syngeneic donors

PATIENT CHARACTERISTICS:

- Creatinine clearance = 40 mL/min

- Total bilirubin = 2 mg/dL

- AST = 3 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- DLCO = 40% with no symptomatic pulmonary disease

- LVEF = 30% by MUGA or ECHO

- No uncontrolled diabetes mellitus or active serious infection

- No known hypersensitivity to E.coli-derived products

- No HIV infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 4 weeks should elapse between prior standard cytotoxic chemotherapy,
radiation therapy, or surgery and the planned start of the preparative regimen on day
-7



Age minimum: N/A
Age maximum: 69 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Leukemia

Lymphoma

Lymphoproliferative Disorder

Multiple Myeloma and Plasma Cell Neoplasm

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasms

Intervention(s)

Biological: anti-thymocyte globulin

Biological: donor lymphocytes

Biological: filgrastim

Biological: therapeutic allogeneic lymphocytes

Drug: busulfan

Drug: fludarabine phosphate

Drug: methotrexate

Drug: mycophenolate mofetil

Drug: tacrolimus

Other: pharmacological study

Other: reduced-intensity transplant conditioning procedure

Procedure: allogeneic hematopoietic stem cell transplantation

Procedure: peripheral blood stem cell transplantation

Primary Outcome(s)

Comparison of EFS distribution to that of CALGB-100002 [Time Frame: No]

Event-free survival (EFS) [Time Frame: No]

Secondary Outcome(s)

Complete (> 90%) or mixed donor chimerism [Time Frame: No]

Complete response rate [Time Frame: No]

Graft-versus-host disease at 6 months [Time Frame: No]

Overall survival [Time Frame: No]

Rate of opportunistic infections [Time Frame: No]

Secondary ID(s)

CALGB-100601

CDR0000667954

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)