Graft Rejection
Primary
· 100 days
Measurement of donor cells vs. recipient cells
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 3 |
Last reviewed · How we verify
NCT02581007
Reduced Intensity Conditioning Transplant Using Haploidentical Donors
Completed
Phase 2
Results posted
Last updated 27 April 2023
What this trial tests
Phase 2 trial testing Fludarabine in Chronic Myelogenous Leukemia in 25 participants. Completed in 28 December 2020.
Timeline
26 October 2015
Primary endpoint
5 November 2019
5 November 2019
28 December 2020
Quick facts
| Lead sponsor | Northside Hospital, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 26 October 2015 |
| Primary completion | 5 November 2019 |
| Estimated completion | 28 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fludarabine (FLUDARABINE) — full drug profile →
- Melphalan (melphalan) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- peripheral blood stem cell transplant — full drug profile →
Conditions studied
- Chronic Myelogenous Leukemia — all drugs for Chronic Myelogenous Leukemia →
- Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
- Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
Sponsor
Northside Hospital, Inc.
Who can join
Adults 18 to 75, any sex, with Chronic Myelogenous Leukemia or Acute Myelogenous Leukemia. 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.
Overall Survival
Secondary
· 2 years
Number of participants still alive 2 years after transplant
1 yr post-transplant
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 68 | 46 – 82 |
2 yr post-transplant
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 56 | 33 – 74 |
Relapse Incidence
Secondary
· 2 years
Number of patients with disease reoccurrence at 1 and 2 years post-transplant
1 yr post-transplant
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 24 | 10 – 42 |
2 yr post-transplant
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 36 | 17 – 55 |
GVHD Incidence
Secondary
· 100 days
The number of participants that developed graft-versus-host-disease before or at 100 days after transplant
Grades II to IV acute GVHD
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 20 | 8 – 37 |
Grades III to IV acute GVHD
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 8 | 2 – 22 |
Moderate chronic GVHD
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 16 | 5 – 33 |
Severe chronic GVHD
| Group | Value | 95% CI |
|---|---|---|
| Reduced-Intensity Mismatched Transplant | 12 | 3 – 27 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 100 days for adverse events, overall survival over 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Reduced-Intensity Mismatched Transplant
Serious: 23/25 (92%)
Deaths: 3/25
Serious adverse events (30 terms)
| Reaction | System | Reduced-Intensity Mismatch… |
|---|---|---|
| fever | General disorders | — |
| hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| bacteremia infection | Infections and infestations | — |
| sepsis | Infections and infestations | — |
| nausea | Gastrointestinal disorders | — |
| vomiting | Gastrointestinal disorders | — |
| diarrhea | Gastrointestinal disorders | — |
| pericardial effusion | Cardiac disorders | — |
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | — |
| thrombocytopenia | Investigations | — |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| confusion | Nervous system disorders | — |
| esophagitis | Gastrointestinal disorders | — |
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| renal failure | Renal and urinary disorders | — |
| sinusitis | Infections and infestations | — |
| chest pain | General disorders | — |
| mucositis | Gastrointestinal disorders | — |
| tachycardia | Cardiac disorders | — |
| elevated liver enzymes | Metabolism and nutrition disorders | — |
| hallucinations | Psychiatric disorders | — |
| cardiac arrest | Cardiac disorders | — |
| anorexia | Gastrointestinal disorders | — |
| graft-versus-host-disease | Immune system disorders | — |
| superficial venous thrombosis | Cardiac disorders | — |
Other adverse events (17 terms — click to expand)
| Reaction | System | Reduced-Intensity Mismatch… |
|---|---|---|
| leukopenia | Investigations | — |
| neutropenia | Investigations | — |
| thrombocytopenia | Investigations | — |
| anemia | Investigations | — |
| elevated liver enzymes | Metabolism and nutrition disorders | — |
| rash | Skin and subcutaneous tissue disorders | — |
| hypokalemia | Metabolism and nutrition disorders | — |
| hypertension | Cardiac disorders | — |
| hyperglycemia | Metabolism and nutrition disorders | — |
| BK virus | Renal and urinary disorders | — |
| hypocalcemia | Metabolism and nutrition disorders | — |
| hyponatremia | Metabolism and nutrition disorders | — |
| weight loss | Gastrointestinal disorders | — |
| syncope | Nervous system disorders | — |
| urinary tract infection | Renal and urinary disorders | — |
| hypomagnesemia | Metabolism and nutrition disorders | — |
| hypermagnesemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: fever, hypoxia, bacteremia infection, sepsis, nausea, vomiting, diarrhea, pericardial effusion.
Data from ClinicalTrials.gov NCT02581007 adverse events section.
Sponsor's own description
This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Treatment of Multiple Myeloma and the Role of Melphalan in the Era of Modern Therapies-Current Research and Clinical Approaches.
Poczta A, Rogalska A, Marczak A. · · 2021 · cited 40× · PMID 33922721 · DOI 10.3390/jcm10091841
Verify or expand the search:
- PubMed search for NCT02581007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Northside Hospital, Inc. trials
Trials by the same sponsor.
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- NCT06337331 — Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant · Phase 2 · withdrawn
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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 NCT02581007 (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 Northside Hospital, Inc.
- Last refreshed: 27 April 2023
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/NCT02581007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing