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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Genzyme, a Sanofi Company | INDUSTRY |
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Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell.
This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clofarabine | Other | Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clofarabine | Drug | Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Phase I-II Participants: Overall Response Rate (ORR) | Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | after at most 6 28-day cycles |
| Phase I Participants Only: Overall Response Rate (ORR) | Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | after at most 6 28-day cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) | To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Abramson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clofarabine 1 mg | Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
| FG001 | Clofarabine 2 mg | Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase I |
|
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| after at most 6 28-day cycles |
| All Phase I-II Participants: Progression-free Survival (PFS) | Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | at 1 and 2 years |
| All Phase I-II Participants: Overall Survival (OS) | Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | 3 years |
| All Phase I-II Participants: Safety | Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | during 6 28-day cycles and 90 days out |
| Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) | To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | after at most 6 28-day cycles |
| Phase I Participants: Progression-free Survival (PFS) | Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | at 17 months |
| All Phase I Participants: Overall Survival (OS) | Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | at 17 months |
| Phase I Participants: Safety | Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | during 6 28-day cycles and 90 days out |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| FG002 | Clofarabine 4 mg | Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
| FG003 | Clofarabine: 3 mg | Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
| COMPLETED |
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| NOT COMPLETED |
|
| Phase II |
|
Phase I participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Clofarabine Phase I | Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Number of prior regimens | Median | Full Range | number of prior regimens |
| |||||||||||||||||
| Histologies | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All Phase I-II Participants: Overall Response Rate (ORR) | Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine | Posted | Number | 95% Confidence Interval | percentage of participants | after at most 6 28-day cycles |
|
|
| |||||||||||||||||||||||||
| Primary | Phase I Participants Only: Overall Response Rate (ORR) | Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Phase I participants only | Posted | Mean | 90% Confidence Interval | percentage of participants | after at most 6 28-day cycles |
|
| ||||||||||||||||||||||||||
| Secondary | Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) | To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | only participants from phase I-II trial who were treated at the RP2D (3mg) | Posted | Number | 95% Confidence Interval | percentage of participants | after at most 6 28-day cycles |
|
| ||||||||||||||||||||||||||
| Secondary | All Phase I-II Participants: Progression-free Survival (PFS) | Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine | Posted | Number | 95% Confidence Interval | percentage of patients | at 1 and 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | All Phase I-II Participants: Overall Survival (OS) | Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | All Phase I-II Participants: Safety | Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine | Posted | Count of Participants | Participants | during 6 28-day cycles and 90 days out |
|
| |||||||||||||||||||||||||||
| Secondary | Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) | To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Phase I participants only who were treated at the RP2D (3mg) | Posted | Count of Participants | Participants | after at most 6 28-day cycles |
|
| |||||||||||||||||||||||||||
| Secondary | Phase I Participants: Progression-free Survival (PFS) | Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Phase I participants only | Posted | Mean | 90% Confidence Interval | percentage of participants | at 17 months |
|
| ||||||||||||||||||||||||||
| Secondary | All Phase I Participants: Overall Survival (OS) | Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | Phase I participants only | Posted | Mean | 90% Confidence Interval | percentage of participants | at 17 months |
|
| ||||||||||||||||||||||||||
| Secondary | Phase I Participants: Safety | Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg) | Phase I participants only | Posted | Count of Participants | Participants | during 6 28-day cycles and 90 days out |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clofarabine | Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. | 15 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| |||
| CNS Cerebrovascular Ischemia | Nervous system disorders |
| |||
| CNS Hemorrhage | Nervous system disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Death (due to disease Progression) | Blood and lymphatic system disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Febrile Neutropenia | Blood and lymphatic system disorders |
| |||
| Fever | General disorders |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Infection | Infections and infestations |
| |||
| Kidney Failure | Renal and urinary disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Pain - Left Flank | General disorders |
| |||
| Pericarditis | Cardiac disorders |
| |||
| Petechia | Blood and lymphatic system disorders |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| suspected GI Bleed | Gastrointestinal disorders |
| |||
| Suspected respiratory tract infection | Infections and infestations |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Weakness in legs | Musculoskeletal and connective tissue disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Platelets | Blood and lymphatic system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Leukocytosis | Blood and lymphatic system disorders |
| |||
| Head/headache | General disorders |
| |||
| Rash/desquamation | Skin and subcutaneous tissue disorders |
| |||
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders |
| |||
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders |
| |||
| Brachial plexopathy | Nervous system disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| AST, SGOT | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Movements involuntary | Nervous system disorders |
| |||
| Back, pain | General disorders |
| |||
| Joint, pain | General disorders |
| |||
| Abdomen, pain | General disorders |
| |||
| Chemoradiation dermatitis | Skin and subcutaneous tissue disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Alkaline phosphatase | Metabolism and nutrition disorders |
| |||
| Edema limb | Blood and lymphatic system disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Allergic rhinitis | Immune system disorders |
| |||
| Pruritus/itching | Skin and subcutaneous tissue disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Lymphopenia | Blood and lymphatic system disorders |
| |||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders |
| |||
| Insomnia | General disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Infection Gr0-2 neut, upper airway | Infections and infestations |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Arthritis | Musculoskeletal and connective tissue disorders |
| |||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders |
| |||
| Pelvic, pain | General disorders |
| |||
| Infection Gr0-2 neut, skin | Infections and infestations |
| |||
| Cardiac-other | Cardiac disorders |
| |||
| Fever w/o neutropenia | General disorders |
| |||
| Weight loss | General disorders |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| Pain-other | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Abramson, MD | Massachusetts General Hospital Cancer Center | 617-724-4000 | jabramson@mgh.harvard.edu |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D007119 | Immunoblastic Lymphadenopathy |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
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| diffuse large B-cell lymphoma (DLBCL) |
|
| marginal zone lymphoma (MZL) |
|
| mantle cell lymphoma (MCL) |
|
| T-cell lymphoma (TCL) |
|
| lymphoplasmacytic lymphoma (LPL) |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Anemia |
| |||||
| Neutropenia |
| |||||
| Thrombocytopenia |
| |||||
| Fatigue |
| |||||
| Neutropenic fever |
| |||||
| Grade 3-4 infections |
| |||||
| Any grade 3-4 toxicity |
|