Clinical trial · Interventional
FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
NCT00381004CI-TRIAL-00020536completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its relationship to response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Sargramostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FCR + Sargramostim
- description
- Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m\^2 IV Days 2-4; Course 2-6: 25 mg/m\^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m\^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m\^2 Days 1-3. Rituximab - Course 1: 375 mg/m\^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m\^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m\^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m\^2 SQ Days -1 and 4-10.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Sargramostim
- Drug: Rituximab
Primary outcomes (2)
- measure
- Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.
- timeFrame
- Baseline to 6 Months
- description
- Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)\</=4x10\^9/L, Hb\>11 g/dL, absolute neutrophil count (ANC)\>/=1.5x109/L, \& platelet count\>100x109/L. Bone marrow:\<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb\>11 g/dL or 50% improvement (imp.) in deviation, or ANC\>/=1.5x109/L or 50% imp., or platelet\>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC\</=4x109/L + Hb\>11 g/dL, ANC\>/=1.5x109/L \& platelet count\>100x109/L; \<30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC\>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression \&/or appearance new malignant disease; Reappearance bone marrow disease.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) with indication for therapy. Indications for therapy include at least one of the following: (1) one or more disease-related symptoms \[fever, night sweats, weight loss \> 10% in prior 6 months, pronounced fatigue\]; (2) advanced stage disease (Rai stage \>/= 3 or Binet stage C); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of \< 6 months. * Patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of CLL, CLL/PLL, or SLL (small lymphocytic lymphoma). * Beta-2-microglobulin \</= 4 mg/dL. * Adequate liver function (total bilirubin \</= 2.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) \</=4 x ULN) and renal function (serum creatinine \</= 2.0 mg/dL and/or creatinine clearance \< 30 mL/hour). Patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the Principal Investigator, but upper limits for creatinine even under these circumstances must be creatinine \< 3mg/dL and bilirubin \< 6 mg/dL. Patients with Gilbert's syndrome may be entered on study with bilirubin levels \</= 4 mg/dL. * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. * Signed informed consent in keeping with the policies of the hospital. * Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as \>/= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment.. Exclusion Criteria: * Active hepatitis B (at least one of the following markers positive: HBsAg, hepatitis B e antigen (HBeAg), immunoglobulin M (IgM) anti-HBc, hepatitis B virus (HBV) DNA). * Concurrent chemotherapy or immunotherapy. * Pregnant patients. * History of HIV * Symptomatic central nervous system (CNS) disease
References
Publications (0)
Data not yet available
No reference posted for this study.