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NCT02629809

Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia

Active, enrolled Phase 2 Last updated 6 March 2026
What this trial tests

Phase 2 trial testing Cyclophosphamide in Chronic Lymphocytic Leukemia in 81 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
18 March 2016
Primary endpoint
31 March 2028
31 March 2028

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment81
Start date18 March 2016
Primary completion31 March 2028
Estimated completion31 March 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab together may work better in treating chronic lymphocytic leukemia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. From Biology to Therapy: The CLL Success Story.
    Yosifov DY, Wolf C, Stilgenbauer S, Mertens D. · · 2019 · cited 48× · PMID 31723816 · DOI 10.1097/hs9.0000000000000175
  2. Ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) regimen for chronic lymphocytic leukemia (CLL) with mutated IGHV and without TP53 aberrations.
    Jain N, Thompson P, Burger J, Ferrajoli A, et al · · 2021 · cited 34× · PMID 34007049 · DOI 10.1038/s41375-021-01280-8
  3. The role of combined fludarabine, cyclophosphamide and rituximab chemoimmunotherapy in chronic lymphocytic leukemia: current evidence and controversies.
    Skarbnik AP, Faderl S. · · 2017 · cited 17× · PMID 28246553 · DOI 10.1177/2040620716681749
  4. Utility of measurable residual disease for predicting treatment outcomes with BCR- and BCL2-Targeted therapies in patients with CLL.
    Wierda WG, Kipps TJ, Al-Sawaf O, Chyla B, et al · · 2022 · cited 3× · PMID 35983732 · DOI 10.1080/10428194.2022.2098291
  5. Pharmacotherapy of relapsed/refractory chronic lymphocytic leukemia.
    Abou Zahr A, Bose P, Keating MJ. · · 2017 · cited 1× · PMID 28446054 · DOI 10.1080/14656566.2017.1324420
  6. First-line therapy for young patients with CLL.
    Jain N, O'Brien S. · · 2016 · cited 1× · PMID 27913473 · DOI 10.1182/asheducation-2016.1.146
  7. EHA2024 Hybrid Congress
    · 2024
  8. Abstract Book for the 27th Congress of the European Hematology Association
    · 2022

Verify or expand the search:

Other trials of Cyclophosphamide

Trials testing the same drug.

Other recruiting trials for Chronic Lymphocytic Leukemia

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02629809.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing