Patients with Advanced Chronic Lymphocytic Leukemia MedDRA version: 12.1 Level: LLT Classification code 10008956 Term: Chronic lymphatic leukaemia
Conditions
Interventions
Trade Name: MABTHERA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
Sponsors
FRED HUTCHINSON CANCER RESEARCH CENTER UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE SEATTLE CHILDREN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with a diagnosis of CLL (or small lymphocytic lymphoma) or Diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL. 2.Patients with B-Cell CLL or PLL who: a. Failed to meet NCI Working Group criteria2 (Appendix I) for complete or partial response after therapy with regimens containing fludarabine (or another nucleoside analog, e.g. 2-CDA, pentostatin) or with disease relapse within 12 months after completing therapy with fludarabine (or another nucleoside analog) containing regimen. b. Failed FCR or PCR combination chemotherapy at any time point. c. Patients with novo or acquired 17p deletion cytogenetic abnormality. Patients should have received induction chemotherapy but could be transplanted in 1st CR. 3.Patients who have suitable HLA-matched related or unrelated donors willing to receive G-CSF, undergo leukopharesis to collect PBMC, and to donate stem cells. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Infection with HIV. 2. Active diagnosis of CNS involvement with CLL. For LP requirement, see Appendix O. 3. Patients unwilling to use contraceptive techniques before and for 12 months after HCT 4. Pregnant women or females who are breastfeeding. 5. The addition of cytotoxic agents for cytoreduction with the exception of tyrosine kinase inhibitors (such as imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning. 6. Performance status: Karnofsky score < 60 (see Appendix B) for adult patients Lansky Play-Performance Score < 40 (Appendix C) for pediatric patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether nonmyeloablative conditioning and allogeneic HCT improves survival at 18 months for patients with fludarabine-refractory, FCR-failed, or del 17p CLL over that of historical controls (45% at 18 months) given CAMPATH-1H.;Primary end point(s): Determine whether nonmyeloablative conditioning and allogeneic HCT improves survival at 18 months for patients with fludarabine-refractory, FCR-failed, or del 17p CLL over that of historical controls (45% at 18 months) given CAMPATH-1H.;Secondary Objective: 1.Estimate the overall response rate (CR + PR) by standard morphologic, flow cytometric, and molecular techniques. 2.Assess the rate of relapse/progression. 3.Define incidences of RRT and infections within the first 200 days and the incidence of TRM within the first year. 4.Estimate incidences of grade II-III and III-IV acute GVHD and chronic GVHD. 5.Assess the impacts of Rituximab a.Determine whether the addition fo Rituximab to the nonmyeloablative conditioning and allogeneic HCT improves survival at 18 months over our historical data (57% at 18 months). b.Determine the incidence of serious adverse events with the addition of Rituximab in comparison to historical data of unrelated nonmyeloablative HCT. c.Evaluate the pharmacokinetics of Rituximab. d.Evaluate B-cell and T-cell immune reconstitution in comparison to historical data of unrelated nonmyeloablative HCT. | — |
Countries
Italy
Outcome results
None listed