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Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
Phase 2 trial testing Cyclophosphamide in Stage I Chronic Lymphocytic Leukemia in 418 participants. Completed in 15 April 2023.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 418 |
| Start date | 15 January 2008 |
| Primary completion | 1 December 2014 |
| Estimated completion | 15 April 2023 |
| Sites | 364 locations across Canada, United States |
National Cancer Institute (NCI)
18 and older, any sex, with Stage I Chronic Lymphocytic Leukemia or Stage II Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of participants who were alive and progression free at 2 years.
| Group | Value | 95% CI |
|---|---|---|
| Arm A, FR in Non-del(11q22.3) | 0.64 | 0.57 – 0.71 |
| Arm B, FR+L in Non-del(11q22.3) | 0.71 | 0.63 – 0.78 |
| Arm C1, FCR in Non-del(11q22.3) | 0.74 | 0.66 – 0.80 |
Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus \>= 1 of the following: \>= 1500/uL polymorphonuclear leukocytes, \> 100,000/uL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Rituximab, Fludarabine Phosphate) | 75 | 68 – 81 |
| Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide) | 69 | 61 – 76 |
| Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 71 | 63 – 78 |
Percentage of del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus \>= 1 of the following: \>= 1500/uL polymorphonuclear leukocytes, \> 100,000/uL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.
| Group | Value | 95% CI |
|---|---|---|
| Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 59 | 42 – 75 |
| Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide) | 74 | 58 – 86 |
Proportion of del (11q22.3) participants who were alive and progression free at 2 years.
| Group | Value | 95% CI |
|---|---|---|
| Arm C2, FCR in Del(11q22.3) | 0.56 | 0.38 – 0.72 |
| Arm D, FCR+L in Del(11q22.3) | 0.65 | 0.48 – 0.79 |
Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: \>= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, \>= 50% increase in the product of at least two lymphnodes, \>= 50% increase in the enlargement of the liver and/or spleen.
| Group | Value | 95% CI |
|---|---|---|
| Arm A, FR in Non-del(11q22.3) | 43.5 | 32.8 – 49.9 |
| Arm B, FR+L in Non-del(11q22.3) | 66.0 | 44.5 – NA |
| Arm C1, FCR in Non-del(11q22.3) | 78.0 | 57.9 – NA |
Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Arm C2, FCR in Del(11q22.3) | 35.5 | 21.8 – 65.5 |
| Arm D, FCR+L in Del(11q22.3) | 44.6 | 25.7 – 50.7 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Rituximab, Fludarab… | Arm B (Rituximab, Fludarab… | Arm C (Rituximab, Fludarab… | Arm D (Rituximab, Fludarab… |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Blood glucose increased | Metabolism and nutrition disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Leukocyte count decreased | Investigations | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Serum calcium decreased | Metabolism and nutrition disorders | — | — | — | — |
| Serum potassium decreased | Metabolism and nutrition disorders | — | — | — | — |
| Serum sodium decreased | Metabolism and nutrition disorders | — | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Serum phosphate decreased | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Reaction | System | Arm A (Rituximab, Fludarab… | Arm B (Rituximab, Fludarab… | Arm C (Rituximab, Fludarab… | Arm D (Rituximab, Fludarab… |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Leukocyte count decreased | Investigations | — | — | — | — |
| Blood glucose increased | Metabolism and nutrition disorders | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Rash desquamating | Skin and subcutaneous tissue disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Serum calcium decreased | Metabolism and nutrition disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Sweating | Skin and subcutaneous tissue disorders | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Serum sodium decreased | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Serum albumin decreased | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — |
| Serum potassium decreased | Metabolism and nutrition disorders | — | — | — | — |
| Chest pain | General disorders | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
Most-reported serious reactions: Hemoglobin decreased, Fatigue, Neutrophil count decreased, Platelet count decreased, Blood glucose increased, Nausea, Cough, Chills.
Data from ClinicalTrials.gov NCT00602459 adverse events section.
This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. 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. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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