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NCT01408160
A Phase 1 Study of the Deglycosylated Ricin A Chain-containing Combined Anti-CD19 and Anti-CD22 Immunotoxin Combotox in Combination With High-Dose Cytarabine in Adult Relapsed or Refractory B-lineage Acute Lymphoblastic Leukemia
Phase 1 trial testing Cytarabine in Adult B Acute Lymphoblastic Leukemia in 18 participants. Terminated before completion.
26 June 2018
Quick facts
| Lead sponsor | Albert Einstein College of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 April 2013 |
| Primary completion | 26 June 2018 |
| Estimated completion | 26 June 2018 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Cytarabine — full drug profile →
- Deglycosylated Ricin A Chain-Conjugated Anti-CD19/Anti-CD22 Immunotoxins — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Pharmacological Study — full drug profile →
Conditions studied
- Adult B Acute Lymphoblastic Leukemia — all drugs for Adult B Acute Lymphoblastic Leukemia →
- Recurrent Adult Acute Lymphoblastic Leukemia — all drugs for Recurrent Adult Acute Lymphoblastic Leukemia →
Sponsor
Albert Einstein College of Medicine
Who can join
18 and older, any sex, with Adult B Acute Lymphoblastic Leukemia or Recurrent Adult Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Occurrence of dose-limiting toxicity, defined as grade 3 or greater non-hematological adverse event attributable to Combotox, graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 28 days
Sponsor's own description
This phase I trial studies the side effects and the best dose of deglycosylated ricin A chain-conjugated anti-cluster of differentiation (CD)19/anti-CD22 immunotoxins when given together with cytarabine in treating patients with B-cell acute lymphoblastic leukemia that has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotoxins, such as deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins, can find certain cancer cells and kill them without harming normal cells. Drugs used in chemotherapy, such as cytarabine, 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. Giving deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins with cytarabine may kill more cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Acute lymphoblastic leukemia: a comprehensive review and 2017 update.
Terwilliger T, Abdul-Hay M. · · 2017 · cited 765× · PMID 28665419 · DOI 10.1038/bcj.2017.53 -
Immunotoxins: the role of the toxin.
Antignani A, Fitzgerald D. · · 2013 · cited 91× · PMID 23965432 · DOI 10.3390/toxins5081486 -
Therapeutic Targeting of Siglecs using Antibody- and Glycan-Based Approaches.
Angata T, Nycholat CM, Macauley MS. · · 2015 · cited 83× · PMID 26435210 · DOI 10.1016/j.tips.2015.06.008 -
Immunotoxins for leukemia.
Wayne AS, Fitzgerald DJ, Kreitman RJ, Pastan I. · · 2014 · cited 82× · PMID 24578503 · DOI 10.1182/blood-2014-01-492256 -
Immunotherapy targets in pediatric cancer.
Orentas RJ, Lee DW, Mackall C. · · 2012 · cited 35× · PMID 22645714 · DOI 10.3389/fonc.2012.00003 -
Linked-in: design and efficacy of antibody drug conjugates in oncology.
Feld J, Barta SK, Schinke C, Braunschweig I, et al · · 2013 · cited 29× · PMID 23651630 · DOI 10.18632/oncotarget.924 -
Recent advances and novel treatment paradigms in acute lymphocytic leukemia.
Papadantonakis N, Advani AS. · · 2016 · cited 21× · PMID 27695616 · DOI 10.1177/2040620716652289 -
Synergy of sequential administration of a deglycosylated ricin A chain-containing combined anti-CD19 and anti-CD22 immunotoxin (Combotox) and cytarabine in a murine model of advanced acute lymphoblastic leukemia.
Barta SK, Zou Y, Schindler J, Shenoy N, et al · · 2012 · cited 21× · PMID 22448921 · DOI 10.3109/10428194.2012.679267
Verify or expand the search:
- PubMed search for NCT01408160
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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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)
- Trial protocol + status: ClinicalTrials.gov NCT01408160 (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 Albert Einstein College of Medicine
- Last refreshed: 4 September 2019
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/NCT01408160.
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