Maximum Tolerated Dose
Primary
· 2 years
| Group | Value | 95% CI |
|---|---|---|
| Clofarabine | 20 |
Last reviewed · How we verify
NCT00416351
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Completed
Phase 1, PHASE2
Results posted
Last updated 17 May 2022
What this trial tests
Phase 1, PHASE2 trial testing clofarabine in Leukemia in 29 participants. Completed in 1 March 2021.
Timeline
27 June 2006
Primary endpoint
1 March 2021
1 March 2021
1 March 2021
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 27 June 2006 |
| Primary completion | 1 March 2021 |
| Estimated completion | 1 March 2021 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- clofarabine (CLOFARABINE) — full drug profile →
Conditions studied
- Leukemia — all drugs for Leukemia →
- Lymphoma — all drugs for Lymphoma →
- Small Intestine Cancer — all drugs for Small Intestine Cancer →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
Adults 2 to 120, any sex, with Leukemia or Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response Rate for Participants With Non-Hodgkin's Lymphoma
Primary
· 2 years
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
| Group | Value | 95% CI |
|---|---|---|
| 4 mg/m2/Day Clofarabine | 0 | |
| 8 mg/m2/Day Clofarabine | 1 | |
| 13.2 mg/m2/Day Clofarabine | 1 | |
| 20 mg/m2/Day Clofarabine | 1 | |
| 28 mg/m2/Day Clofarabine | 0 | |
| 4 mg/m2/Day Clofarabine | 0 | |
| 8 mg/m2/Day Clofarabine | 0 | |
| 13.2 mg/m2/Day Clofarabine | 0 | |
| 20 mg/m2/Day Clofarabine | 1 | |
| 28 mg/m2/Day Clofarabine | 0 | |
| 4 mg/m2/Day Clofarabine | 0 | |
| 8 mg/m2/Day Clofarabine | 1 | |
| 13.2 mg/m2/Day Clofarabine | 0 | |
| 20 mg/m2/Day Clofarabine | 2 | |
| 28 mg/m2/Day Clofarabine | 1 | |
| 4 mg/m2/Day Clofarabine | 1 | |
| 8 mg/m2/Day Clofarabine | 1 | |
| 13.2 mg/m2/Day Clofarabine | 2 | |
| 20 mg/m2/Day Clofarabine | 11 | |
| 28 mg/m2/Day Clofarabine | 3 |
Participants Evaluated for Toxicity
Secondary
· 2 years
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
| Group | Value | 95% CI |
|---|---|---|
| 4 mg/m2/Day Clofarabine | 1 | |
| 8 mg/m2/Day Clofarabine | 3 | |
| 13.2 mg/m2/Day Clofarabine | 4 | |
| 20 mg/m2/Day Clofarabine | 17 | |
| 28 mg/m2/Day Clofarabine | 4 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
4 mg/m2/Day Clofarabine
Serious: 0/1 (0%)
Deaths: 1/1
8 mg/m2/Day Clofarabine
Serious: 1/3 (33%)
Deaths: 3/3
13.2 mg/m2/Day Clofarabine
Serious: 1/4 (25%)
Deaths: 3/4
20 mg/m2/Day Clofarabine
Serious: 13/17 (76%)
Deaths: 12/17
28 mg/m2/Day Clofarabine
Serious: 4/4 (100%)
Deaths: 4/4
Serious adverse events (26 terms)
| Reaction | System | 4 mg/m2/Day Clofarabine | 8 mg/m2/Day Clofarabine | 13.2 mg/m2/Day Clofarabine | 20 mg/m2/Day Clofarabine | 28 mg/m2/Day Clofarabine |
|---|---|---|---|---|---|---|
| Infection, other | Infections and infestations | — | — | — | — | — |
| Creatinine | Investigations | — | — | — | — | — |
| Fever (in the absence of neutropenia) | General disorders | — | — | — | — | — |
| Hemoglobin | Blood and lymphatic system disorders | — | — | — | — | — |
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | — | — | — | — | — |
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | — | — | — | — | — |
| Pain - Other (specify) | General disorders | — | — | — | — | — |
| Platelets | Investigations | — | — | — | — | — |
| Calcium, high (hypercalcemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Hemorrhage/Bleeding, other | Blood and lymphatic system disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Inf norm ANC/gr1/2 neut-Bronchitis NOS | Infections and infestations | — | — | — | — | — |
| Inf norm ANC/gr1/2 neut-Joint | Infections and infestations | — | — | — | — | — |
| Inf unknown ANC-Pneumonia(lung) | Infections and infestations | — | — | — | — | — |
| Infection w/ Gr 3/4 neut, Blood | Infections and infestations | — | — | — | — | — |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | — | — | — | — | — |
| Ocular/Visual - Other (specify) | Eye disorders | — | — | — | — | — |
| Odor (patient odor) | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Rigors/chills | General disorders | — | — | — | — | — |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | — | — | — | — | — |
Other adverse events (49 terms — click to expand)
| Reaction | System | 4 mg/m2/Day Clofarabine | 8 mg/m2/Day Clofarabine | 13.2 mg/m2/Day Clofarabine | 20 mg/m2/Day Clofarabine | 28 mg/m2/Day Clofarabine |
|---|---|---|---|---|---|---|
| Lymphopenia | Investigations | — | — | — | — | — |
| Hemoglobin | Investigations | — | — | — | — | — |
| Leukocytes (total WBC) | Investigations | — | — | — | — | — |
| Platelets | Investigations | — | — | — | — | — |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | — | — | — | — | — |
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — | — | — | — | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Calcium, high (hypercalcemia) | Investigations | — | — | — | — | — |
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Pain - Other (specify) | General disorders | — | — | — | — | — |
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Constipation | General disorders | — | — | — | — | — |
| Creatinine | Investigations | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Infection, other | Infections and infestations | — | — | — | — | — |
| Pain - Oral cavity | Gastrointestinal disorders | — | — | — | — | — |
| Pulm/upp respiratory - Other (spec) | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Weight loss | Investigations | — | — | — | — | — |
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | — | — | — | — | — |
| ALT, SGPT | Investigations | — | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — |
| AST, SGOT | Metabolism and nutrition disorders | — | — | — | — | — |
| Bilirubin (hyperbilirubinemia) | Investigations | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Edema: Limb | General disorders | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Infection w/ Gr 3/4 neut, Skin (cellulites) | Infections and infestations | — | — | — | — | — |
Most-reported serious reactions: Infection, other, Creatinine, Fever (in the absence of neutropenia), Hemoglobin, Inf unknown ANC-Cellulitis(skin), Mucositis (Clin exam)- Oral cavity, Pain - Other (specify), Platelets.
Data from ClinicalTrials.gov NCT00416351 adverse events section.
Sponsor's own description
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent progress in DNA methyltransferase inhibitors as anticancer agents.
Zhang Z, Wang G, Li Y, Lei D, et al · · 2022 · cited 96× · PMID 37077808 · DOI 10.3389/fphar.2022.1072651 -
A Review of New Findings in Adult T-cell Leukemia-Lymphoma: A Focus on Current and Emerging Treatment Strategies.
Hermine O, Ramos JC, Tobinai K. · · 2018 · cited 61× · PMID 29411267 · DOI 10.1007/s12325-018-0658-4 -
Recent Advances in Diagnosis and Therapy of Angioimmunoblastic T Cell Lymphoma.
Mohammed Saleh MF, Kotb A, Abdallah GEM, Muhsen IN, et al · · 2021 · cited 20× · PMID 34940095 · DOI 10.3390/curroncol28060456
Verify or expand the search:
- PubMed search for NCT00416351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Memorial Sloan Kettering Cancer Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00416351 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 17 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00416351.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing