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This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clofarabine | Drug | Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Day 7 until Day 30 |
| Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Day 7 until Day 30 |
| Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Day 7 until Day 30 |
| Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Day 7 until Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 1 year | |
| Progression-free Survival (PFS) | Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Artz, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clofarabine, Melphalan, and Alemtuzumab | Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clofarabine, Melphalan, and Alemtuzumab | Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Posted | Number | participants | Day 7 until Day 30 |
|
|
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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, Melphalan, and Alemtuzumab | Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Artz | University of Chicago | 773-834-8980 | aartz@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D011289 | Preleukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| D008558 | Melphalan |
| D000074323 | Alemtuzumab |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Melphalan | Drug | Doses ranging from 100 to 140 mg/m2 |
|
| Campath | Drug | 20mg/d x5 |
|
| Stem Cell Transplant | Procedure | Infusion of donor, bone marrow and auto. |
|
| 1 year |
| Treatment-related Mortality (TRM) | 1 year |
| Relapse Rate | 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Overall Survival (OS) | 74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Primary | Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Posted | Number | participants | Day 7 until Day 30 |
|
|
|
| Primary | Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Posted | Number | participants | Day 7 until Day 30 |
|
|
|
| Primary | Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation | Toxicity was scored according to NCI/CTC version 3 | Posted | Number | participants | Day 7 until Day 30 |
|
|
|
| Secondary | Progression-free Survival (PFS) | Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first. | 74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Treatment-related Mortality (TRM) | 74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Relapse Rate | 74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| 44 |
| 82 |
| 62 |
| 82 |
| Atrial fibrillation | Cardiac disorders |
|
| Cardiovascular disease, unspecified | Cardiac disorders |
|
| Confusion | Psychiatric disorders |
|
| Hypotension | Vascular disorders |
|
| Mental status changes | Psychiatric disorders |
|
| Mucositis | General disorders |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders |
|
| Renal disorder NOS | Renal and urinary disorders |
|
| Hepatobiliary disease NOS | Hepatobiliary disorders |
|
| Atrial flutter | Cardiac disorders |
|
| Confusion | Psychiatric disorders |
|
| Hepatobiliary disease NOS | Hepatobiliary disorders |
|
| Mucositis | General disorders |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders |
|
| Pancreatitis | Gastrointestinal disorders |
|
| Renal disorder NOS | Renal and urinary disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Pseudotumor cerebri | Nervous system disorders |
|
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| D011230 | Precancerous Conditions |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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