Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074282
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2003-12-10
Brief Title:
Pentostatin Cyclophosphamide and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Pentostatin Cyclophosphamide and Rituximab PCR Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as pentostatin cyclophosphamide and CAMPATH-1H work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well pentostatin cyclophosphamide rituximab and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia
PURPOSE This phase II trial is studying how well pentostatin cyclophosphamide rituximab and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate complete remission partial remission PR or nodular PR in patients with relapsed or refractory B-cell chronic lymphocytic leukemia CLL treated with pentostatin cyclophosphamide and rituximab PCR followed by CAMPATH-1H
Determine the presence of minimal residual disease in patients treated with this regimen who achieve a CR or nPR
Secondary
Determine the toxicity of this regimen in these patients
Determine the overall and progression-free survival of patients treated with this regimen
Evaluate the number of patients who after PCR or during PCR for PD only achieve a PR SD or PD and who subsequently convert to a higher response category after CAMPATH-1H
Exploratory
Assess the angiogenic profile ie secretion levels of pro- versus anti-angiogenic molecules of CLL B cell clones as well as bone marrow angiogenesis ie vascular density by immunohistochemistry at baseline after PCR after CAMPATH-1H every six months serum only and at time of response assessment marrow
Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome
Determine surface phenotype by flow cytometry and genetic defects by CLL FISH panel information on CLL-B cell clones and associate with clinical outcome
Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and CAMPATH-1H treatment and assess any association with clinical outcome and toxicities
Primary
Determine the objective response rate complete remission partial remission PR or nodular PR in patients with relapsed or refractory B-cell chronic lymphocytic leukemia CLL treated with pentostatin cyclophosphamide and rituximab PCR followed by CAMPATH-1H
Determine the presence of minimal residual disease in patients treated with this regimen who achieve a CR or nPR
Secondary
Determine the toxicity of this regimen in these patients
Determine the overall and progression-free survival of patients treated with this regimen
Evaluate the number of patients who after PCR or during PCR for PD only achieve a PR SD or PD and who subsequently convert to a higher response category after CAMPATH-1H
Exploratory
Assess the angiogenic profile ie secretion levels of pro- versus anti-angiogenic molecules of CLL B cell clones as well as bone marrow angiogenesis ie vascular density by immunohistochemistry at baseline after PCR after CAMPATH-1H every six months serum only and at time of response assessment marrow
Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome
Determine surface phenotype by flow cytometry and genetic defects by CLL FISH panel information on CLL-B cell clones and associate with clinical outcome
Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and CAMPATH-1H treatment and assess any association with clinical outcome and toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E2903 | OTHER | ECOG-ACRIN | None |