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Active, not recruitingNCT03269669Updated Jul 8, 2026

Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

A Phase 2 interventional study of Bendamustine Hydrochloride and Biopsy Procedure in Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma and Grade 3a Follicular Lymphoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 429 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, 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. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

I. To compare the complete response rate up to 6 cycles after randomization as defined by centrally read positron emission tomography (PET)/computed tomography (CT) (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + umbralisib [TGR-1202] or obinutuzumab + lenalidomide) with obinutuzumab + chemotherapy (cyclophosphamide, doxorubicin hydrochloride [doxorubicin], vincristine sulfate [vincristine], and prednisone [CHOP] or bendamustine hydrochloride [bendamustine]) in patients with early relapsing or refractory follicular lymphoma.

SECONDARY OBJECTIVES:

I. To validate the prognostic association of the m7-FLIPI model, demonstrating that the population of follicular lymphoma patients who respond poorly to chemoimmunotherapy are enriched for having a high-risk m7-FLIPI score, and that the score is associated with progression-free survival (integrated biomarker). (Primary translational medicine) II. To estimate the 30-month sustained complete response rate (CR30) defined by centrally read PET/CT with each of the regimens in this early relapsing or refractory follicular lymphoma population.

III. To estimate best response up to 12 cycles of therapy, progression free survival, duration of response and overall survival with each of the combinations in early relapsing or refractory follicular lymphoma.

IV. To evaluate the adverse effects of each of the regimens in early relapsing or refractory follicular lymphoma.

V. To evaluate the predictive performance of non-invasive genotyping (m7-FLIPI in circulating tumor deoxyribonucleic acid [DNA]) of plasma at study entry relative to standard tumor genotyping (m7-FLIPI) of formalin-fixed paraffin-embedded tumor tissue.

VI. To evaluate the association between the detection of active lymphoma by PET-CT and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (CLOSED TO ACCRUAL): Patients receive obinutuzumab intravenously (IV) on day 1 and umbralisib orally (PO) daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up 12 cycles in the absence of disease progression or unacceptable toxicity.

ARM III:

PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1 and bendamustine IV over 60 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity.

Patients in all arms undergo biopsy and echocardiogram (ECHO) or multigated acquisition scan (MUGA) during screening, and PET/CT scans and collection of blood throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

02

Conditions studied

  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Recurrent Follicular Lymphoma
  • Refractory Follicular Lymphoma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable fludeoxyglucose F-18 (FDG) avid disease on PET/CT; patients that have involvement with large cell lymphoma are not eligible
  • Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration
  • Patients must have bone marrow biopsy performed within 42 days prior to registration
  • Patients must have an indication for therapy as determined by the treating investigator
  • All disease must be assessed and documented on the S1608 FDG-PET/CT assessment form

  • The intent is to enroll patients with follicular lymphoma (FL) relapsed within 2 years of completing their first course of chemotherapy (CHOP or bendamustine based therapy) + anti-CD20 therapy. Patient is still eligible if he/she received radiation therapy or anti-CD20 therapy prior to chemoimmunotherapy or if maintenance anti-CD20 therapy was administered after chemoimmunotherapy

    • Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing CHOP or bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of CHOP or bendamustine; relapsed patients must not have received any intervening chemotherapy
    • Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine; (note that no minimum dose of bendamustine is required)
    • Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible
    • Patients who additionally received any maintenance anti-CD-20 antibody therapy or consolidative radioimmunotherapy within 2 years of the last dose of the CHOP or bendamustine therapy are eligible

    • Involved field or involved site radiation is not considered a line of therapy; examples of eligible prior treatment regimens (note this list is not all inclusive):

      • 1st line rituximab treatment followed years later by bendamustine rituximab
      • Bendamustine rituximab x 4 cycles
      • 1st line rituximab treatment, 2nd line ibritumomab tiuxetan, followed by bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance
      • Bendamustine obinutuzumab x 3 cycles
      • CHOP rituximab x 6 cycles followed by rituximab maintenance
  • For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients prior treatment related toxicities (except alopecia) must have resolved to grade 1 or less prior to registration
  • Patients must have tissue specimens collected prior to registration; patients must be offered participation in biobanking of residual specimens; with patient consent, residuals from the mandatory submission(s) will be banked for future research
  • Patients must be >= 18 years of age
  • All patients must have a Zubrod performance status of 0, 1 or 2
  • Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration
  • Platelets >= 75,000/mcL within 28 days prior to registration
  • Patients must have adequate renal function as documented by a calculated creatinine clearance >= 60 mL/min, within 28 days prior to registration
  • Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (=\< 5 x IULN if secondary to lymphoma, Gilbert's syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
  • Direct bilirubin =\< 1.5 x IULN (=\< 5 x IULN if secondary to lymphoma) within 28 days prior to registration
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x IULN (=\< 5 x IULN secondary to lymphoma) within 28 days prior to registration
  • Patients must have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 42 days prior to registration with a cardiac ejection fraction >= 45%

  • Patients with hepatitis B virus infection must have undetectable hepatitis B virus (HBV) on suppressive therapy and no evidence of HBV-related hepatic damage; patients with hepatitis C virus infection are eligible if complete eradication therapy has been successfully completed, and there is no detectable hepatitis C virus (HVC) or related hepatic damage; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria in addition to the other protocol eligibility criteria:

    • Patient must have no history of acquired immune deficiency syndrome (AIDS)-related complications, other than a history of low CD4+ T-cell count (\< 200/mm\^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low
    • Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia
    • Patient must have serum HIV viral load of \< 200 copies/mm\^3
    • Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy; (recommend a regimen of the integrase inhibitor dolutegravir combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine)
    • Protease inhibitors and once daily formulations containing cobicistat are NOT allowed due to potential pharmacokinetic interactions with leukemia therapy
    • Stavudine and zidovudine (AZT) are NOT allowed because of overlapping toxicity with protocol therapy
  • Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients unable or unwilling to take any listed prophylaxis are NOT eligible
  • No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years
  • Patients must have a complete history and physical examination within 28 days prior to registration
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence [e.g., calendar, ovulation, symptothermal or post ovulation methods] and withdrawal are not acceptable methods of contraception) from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; while taking lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a female who: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; NOTE: patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration
  • Patients must have lactate dehydrogenase (LDH) and beta-2-microglobulin collected within 28 days prior to registration
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion criteria

Exclusion Criteria:

  • Patients must not have clinical evidence of central nervous system involvement by lymphoma since the proposed treatment strategies are not designed to address central nervous system (CNS) involvement adequately; if performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative
  • Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Arm I (obinutuzumab, umbralisib)

    CLOSED TO ACCRUAL: Patients receive obinutuzumab IV on day 1 and umbralisib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

    Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Biological: Obinutuzumab · Procedure: Positron Emission Tomography · Drug: Umbralisib

  • Experimental
    Arm II (obinutuzumab, lenalidomide)

    Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

    Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Echocardiography Test · Drug: Lenalidomide · Procedure: Multigated Acquisition Scan · Biological: Obinutuzumab · Procedure: Positron Emission Tomography

  • Active comparator
    Arm III (obinutuzumab, combination chemotherapy)

    PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, and bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

    Drug: Bendamustine Hydrochloride · Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Drug: Cyclophosphamide · Drug: Doxorubicin Hydrochloride · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Biological: Obinutuzumab · Procedure: Positron Emission Tomography · Drug: Prednisone · Drug: Vincristine Sulfate

Interventions

  • DrugBendamustine Hydrochloride

    Given IV

    Also known as: Belrapzo, Bendamustin Hydrochloride, Bendeka, CEP 18083, CEP-18083, CEP18083, Cytostasan Hydrochloride, Levact, Ribomustin, SyB L-0501, Treakisym, Treanda, VIVIMUSTA

  • ProcedureBiopsy Procedure

    Undergo biopsy

    Also known as: Biopsy, BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo collection of blood

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureComputed Tomography

    Undergo PET/CT scans

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • DrugCyclophosphamide

    Given IV

    Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Frindovyx, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

  • DrugDoxorubicin Hydrochloride

    Given IV

    Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, FI106, hydroxydaunorubicin, Rubex

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • DrugLenalidomide

    Given PO

    Also known as: CC 5013, CC-5013, CC5013, CDC 501, Revlimid

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA

    Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

  • BiologicalObinutuzumab

    Given IV

    Also known as: Anti-CD20 Monoclonal Antibody R7159, GA 101, GA-101, GA101, Gazyva, huMAB(CD20), R 7159, R-7159, R7159, RO 5072759, RO-5072759, RO5072759

  • ProcedurePositron Emission Tomography

    Undergo PET/CT scans

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • DrugPrednisone

    Given PO

    Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

  • DrugUmbralisib

    Given PO

    Also known as: 2-((1S)-1-(4-Amino-3-(3-fluoro-4-(1-methylethoxy)phenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)ethyl)-6-fluoro-3-(3-fluorophenyl)-4H-1-benzopyran-4-one, RP-5264, RP5264, TGR 1202, TGR-1202, TGR1202

  • DrugVincristine Sulfate

    Given IV

    Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

05

What researchers measure

Primary outcomes

  1. Complete response (CR)

    Time frame: Up to 6 cycles

Secondary outcomes

  1. Sustained complete response rate (CR30)

    Defined by centrally read positron emission tomography (PET)/computed tomography (CT).

    Time frame: Up to 30 months

  2. Progression-free survival (PFS)

    Will be calculated using the method of Kaplan-Meier. 95% confidence for the survival estimates will be constructed using the method of Brookmeyer-Crowley. With 31 eligible patients in each arm, progression free survival at a particular time point, and the 30-month sustained response rate can be estimated to within at least +/- 18% with 95% confidence.

    Time frame: From date of registration to date of first observation of progressive disease, or death due to any cause, assessed up to 5 years

  3. Duration of response (CR, partial response [PR])

    Will be calculated using the method of Kaplan-Meier.

    Time frame: From date of first documentation of response to treatment (CR, PR) to date of first documentation of progression, or death due to any cause, assessed up to 5 years

  4. Overall survival (OS)

    Will be calculated using the method of Kaplan-Meier. 95% confidence for the survival estimates will be constructed using the method of Brookmeyer-Crowley. With 31 eligible patients in each arm, OS at a particular time point, and the 30-month sustained response rate can be estimated to within at least +/- 18% with 95% confidence.

    Time frame: Up to 5 years

  5. Incidence of adverse events

    Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 will be utilized for serious adverse events reporting only). Toxicity rates can be estimated to within at least +/- 18% with 95% confidence.

    Time frame: Up to 5 years

  6. Non-invasive genotyping and circulating tumor deoxyribonucleic acid (DNA) assessment

    Sensitivity, specificity, positive predictive value, negative predictive value, and kappa coefficient will be used to evaluate the concordance. Will evaluate the association of detection of active lymphoma by positron emission tomography-computed tomography and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy. Chi-square test will be used to evaluate the association and odds ratio will be calculated

    Time frame: Up to 5 years

  7. Active lymphoma and circulating tumor DNA in plasma

    The Cox proportional hazards model will be used to assess the association and odds ratio will be calculated.

    Time frame: From baseline up to 30 months after initiation of treatment

  8. m7-FLIPI model validation

    The Cox proportional hazards model will be used to assess the association of the m7-FLIPI with to PFS.

    Time frame: Up to 5 years

06

Study locations

429 sites
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska 99508, United States
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska 99508, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Anchorage Oncology Centre
    Anchorage, Alaska 99508, United States
  • Katmai Oncology Group
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California 94531, United States
  • PCR Oncology
    Arroyo Grande, California 93420, United States
  • Sutter Auburn Faith Hospital
    Auburn, California 95602, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Kaiser Permanente Dublin
    Dublin, California 94568, United States
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
  • Kaiser Permanente-Fresno
    Fresno, California 93720, United States
  • Kaiser Permanente South Bay
    Harbor City, California 90710, United States
  • City of Hope Seacliff
    Huntington Beach, California 92648, United States
  • City of Hope at Irvine Lennar
    Irvine, California 92618, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • City of Hope at Long Beach Elm
    Long Beach, California 90813, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
  • Memorial Medical Center
    Modesto, California 95355, United States
  • Kaiser Permanente-Modesto
    Modesto, California 95356, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology
    Mountain View, California 94040, United States
  • City of Hope Newport Beach
    Newport Beach, California 92660, United States
  • Kaiser Permanente Oakland-Broadway
    Oakland, California 94611, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Kaiser Permanente-Ontario
    Ontario, California 91761, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California 94301, United States
  • VA Palo Alto Health Care System
    Palo Alto, California 94304, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Eisenhower Medical Center
    Rancho Mirage, California 92270, United States
  • Kaiser Permanente-Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
  • Kaiser Permanente Downtown Commons
    Sacramento, California 95814, United States
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
  • Kaiser Permanente Sacramento Medical Center
    Sacramento, California 95825, United States
  • Kaiser Permanente-San Diego Mission
    San Diego, California 92108, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California 94903, United States
  • Kaiser San Rafael-Gallinas
    San Rafael, California 94903, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California 95065, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California 95403, United States
  • City of Hope South Pasadena
    South Pasadena, California 91030, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California 94080, United States
  • Kaiser Permanente-Stockton
    Stockton, California 95210, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California 94086, United States
  • City of Hope South Bay
    Torrance, California 90503, United States
  • City of Hope Upland
    Upland, California 91786, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California 95688, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
  • Rocky Mountain Cancer Centers-Aurora
    Aurora, Colorado 80012, United States
  • The Medical Center of Aurora
    Aurora, Colorado 80012, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado 80304, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado 80907, United States
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
  • AdventHealth Porter
    Denver, Colorado 80210, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Midtown
    Denver, Colorado 80218, United States
  • Saint Joseph Hospital - Cancer Centers of Colorado
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Rose
    Denver, Colorado 80220, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Mercy Medical Center
    Durango, Colorado 81301, United States
  • Mountain Blue Cancer Care Center - Swedish
    Englewood, Colorado 80113, United States
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
  • Mountain Blue Cancer Care Center
    Golden, Colorado 80401, United States
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado 81501, United States
  • Banner North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Rocky Mountain Cancer Centers-Greenwood Village
    Greenwood Village, Colorado 80111, United States
  • CommonSpirit Saint Anthony Hospital Cancer Center
    Lakewood, Colorado 80228, United States
  • Rocky Mountain Cancer Centers-Lakewood
    Lakewood, Colorado 80228, United States
  • Rocky Mountain Cancer Centers-Littleton
    Littleton, Colorado 80120, United States
  • AdventHealth Littleton
    Littleton, Colorado 80122, United States
  • Rocky Mountain Cancer Centers-Sky Ridge
    Lone Tree, Colorado 80124, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • Rocky Mountain Cancer Centers-Longmont
    Longmont, Colorado 80501, United States
  • Banner North Colorado Medical Center - Loveland Campus
    Loveland, Colorado 80539, United States
  • AdventHealth Parker
    Parker, Colorado 80138, United States

Showing the first 100 of 429 sites.

07

Registry details

Key details

Study ID
NCT03269669
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Jan 23, 2018
Primary completion
Dec 31, 2025
Completion
Jan 21, 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Paul M Barr
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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