Evidence map›Paper›PMID 34007049›Full record

Trial reportLeukemia2021

Ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) regimen for chronic lymphocytic leukemia (CLL) with mutated IGHV and without TP53 aberrations.

Nitin Jain, Philip Thompson, Jan Burger, Alessandra Ferrajoli, Koichi Takahashi, Zeev Estrov, Gautam Borthakur, Prithviraj Bose, Tapan Kadia, Naveen Pemmaraju and 18 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Leukemia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
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  5. Ibrutinib and Venetoclax for First-Line Treatment of CLL.The New England journal of medicine · 2019
    Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 2 institutions in 1 country.

Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Philip ThompsonDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0003-2086-6031
Jan BurgerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-6177-7572
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Koichi TakahashiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-8027-9659
Zeev EstrovDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-1623-3613
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-7679-6453
Prithviraj BoseDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-4343-5712
Tapan KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-9892-9832
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-1670-6513
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-9140-0610
Marina KonoplevaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-9347-2212
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0003-4465-6119
Naveen GargDepartment of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Xuemei WangDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rashmi Kanagal-ShamannaDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-7829-5249
Keyur PatelDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-5081-2427
Wei WangDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-6821-4556
Jeffrey JorgensenDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sa WangDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Wanda LopezDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ana AyalaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
William PlunkettDepartment of Experimental Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Varsha GandhiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-3172-9166
Hagop KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-1908-3307
Susan O'BrienChao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange, CA, USA.
Michael KeatingDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
William G WierdaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. wwierda@mdanderson.org.ORCID http://orcid.org/0000-0002-7357-270X
The University of Texas MD Anderson Cancer Center · USUniversity of California, Irvine Medical Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Chemoimmunotherapy with combined fludarabine, cyclophosphamide and rituximab (FCR) has been an effective treatment for patients with chronic lymphocytic leukemia (CLL). We initiated a phase II trial for previously untreated patients with CLL with mutated IGHV and absence of del(17p)/TP53 mutation. Patients received ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) for three cycles. Patients who achieved complete remission (CR)/CR with incomplete count recvoery (CRi) with marrow undetectable measurable residual disease (U-MRD) received additional nine cycles of ibrutinib with three cycles of obinutuzumab; all others received nine additional cycles of ibrutinib and obinutuzumab. Patients in marrow U-MRD remission after cycle 12 discontinued all treatment, including ibrutinib. Forty-five patients were treated. The median follow-up is 41.3 months. Among the total 45 treated patients, after three cycles, 38% achieved CR/CRi and 87% achieved marrow U-MRD. After cycle 12, the corresponding numbers were 67% and 91%, respectively. Overall, 44/45 (98%) patients achieved marrow U-MRD as best response. No patient had CLL progression. The 3-year progression-free survival (PFS) and overall survival (OS) were 98% and 98%, respectively. Per trial design, all patients who completed cycle 12 discontinued ibrutinib, providing for a time-limited therapy. Grade 3-4 neutropenia and thrombocytopenia occurred in 58% and 40% patients, respectively. The iFCG regimen with only 3 cycles of chemotherapy is an effective, time-limited regimen for patients with CLL with mutated IGHV and without del(17p)/TP53 mutation.

Indexed as

MutationAdenineAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCyclophosphamideFemaleFollow-Up StudiesHumansImmunoglobulin Heavy ChainsImmunoglobulin Variable RegionLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedAdenineAntibodies, Monoclonal, HumanizedBiomarkers, TumorCyclophosphamidefludarabineibrutinibImmunoglobulin Heavy ChainsImmunoglobulin Variable RegionobinutuzumabPiperidinesTP53 protein, humanTumor Suppressor Protein p53Vidarabine

Identifiers

PMID34007049
PMCPMC11812922
OpenAlexW3160469825

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.