Ofatumumab & Ibrutinib + Allogeneic Bone Marrow Transplant or Consolidation in High Risk Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT02388048|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphoblastic, Chronic||Drug: Ibrutinib + ofatumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Combination of Ofatumumab and Ibrutinib Followed by Allogeneic Bone Marrow Transplant or Consolidation for Pretreated High Risk Patients With Chronic Lymphocytic Leukemia|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Ibrutinib + Ofatumumab
IBRUTINIB 420 mg PO daily in 28-day cycles for a total of 7 cycles (28 weeks).
OFATUMUMAB 300 mg on day 1 of cycle 2 of Ibrutinib, followed by 2000 mg on D8, 15, 22 of cycle 2, D1, 8, 15, 22 of cycle 3, and Day 1 of cycle 4-7.
After induction treatment patients with HLA identical sibling or fully matched MUD donor will be addressed to reduced intensity allogeneic bone marrow transplant, while patients without a suitable donor or who refuse the transplant procedure will receive maintenance treatment by BTK inhibitor (IBRUTINIB 420 mg PO daily in 28-day cycles). Treatment will continue until disease progression or unacceptable toxicity.
Drug: Ibrutinib + ofatumumab
- The number of pretreated patients with high risk CLL who achieve a Complete Response (CR) after the induction therapy with Ibrutinib plus Ofatumumab. [ Time Frame: After 6.5 years from treatment start ]
- Number of patients in Complete Response (CR)/Partial Response (PR) [ Time Frame: After 28 weeks from treatment start ]Overall response rate at the end of induction therapy.
- Number of patients without progression of the disease. [ Time Frame: At 60 months from treatment start ]Progression-free survival
- Number of patients alive [ Time Frame: At 60 months from treatment start ]Overall survival
- Number of patients without events [ Time Frame: At 60 months from treatment start ]Event-free survival
- Number of Minimal Residual Disease-negative Complete Responses [ Time Frame: At 28 weeks from treatment start ]6. To estimate Minimal Residual Disease (MRD) in terms of rate of MRD-negative CRs at the end of induction therapy and after SCT or Ibrutinib maintenance therapy for patients in CR
- Number of adverse events [ Time Frame: At 6.5 years after treatment start ]7. Safety profile and tolerability of the combination of Ofatumumab and Ibrutinib and the ibrutinib as maintenance in terms of type, frequency, severity and relationship of adverse events (AEs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388048
|Study Chair:||Marco Montillo||Department of Hematology, Niguarda Ca' Granda, Milan|
|Study Director:||Francesca R. Mauro||Department of Hematology, Policlinico Umberto I di Roma|