Disease Free Survival at 2 Years
Secondary
· 2 years
Disease Free Survival at 2 years
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 60.8 |
Last reviewed · How we verify
NCT01866839
Preventing Stem Cell Transplant Complications With a Blood Separator Machine
Completed
Phase 1, PHASE2
Results posted
Last updated 21 July 2020
What this trial tests
Phase 1, PHASE2 trial testing Graft Manipulation (CD34+ Selection) in MDS (Myelodysplastic Syndrome) in 41 participants. Completed in 28 June 2018.
Timeline
29 May 2013
Primary endpoint
23 May 2018
23 May 2018
28 June 2018
Quick facts
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 29 May 2013 |
| Primary completion | 23 May 2018 |
| Estimated completion | 28 June 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Graft Manipulation (CD34+ Selection)
Conditions studied
- MDS (Myelodysplastic Syndrome) — all drugs for MDS (Myelodysplastic Syndrome) →
- Myeloproliferative Disorder — all drugs for Myeloproliferative Disorder →
- Lymphoma, Non-Hodgkin — all drugs for Lymphoma, Non-Hodgkin →
- ALL (Acute B-Lymphoblastic Leukemia) — all drugs for ALL (Acute B-Lymphoblastic Leukemia) →
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Who can join
Adults 2 to 80, any sex, with MDS (Myelodysplastic Syndrome) or Myeloproliferative Disorder. 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.
Disease Progression
Secondary
· 3 years
Incidence of relapse / disease progression
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 11 |
Incidence of Acute GVHD
Secondary
· 100 days
Participants who develop acute GVHD
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 26 |
Incidence of Chronic GVHD
Secondary
· 3 years
Participants who develop chronic GVHD
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 14 |
Median Time to ANC>500/mm3
Secondary
· 3 years
Time in days
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 12 | 9 – 28 |
Median Time to Platelets>20K/mm3
Secondary
· 3 years
Time in days
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 15 | 14 – 28 |
Overall Survival
Primary
· 200 days
Determine the rate of overall survival at 200 day
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 36 |
Severity of Acute GVHD
Secondary
· 100 days
Grade I
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 10 |
Severity of Acute GVHD
Secondary
· 100 days
Grade II
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 7 |
Severity of Acute GVHD
Secondary
· 100 days
Grade III
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 8 |
Severity of Acute GVHD
Secondary
· 100 days
Grade IV
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 1 |
Severity of Chronic GVHD
Secondary
· 3 years
Extensive
| Group | Value | 95% CI |
|---|---|---|
| CD34+ Cell Positively Selected Graft Stem Cell Recipient | 10 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CD34+ Cell Positively Selected Graft Stem Cell Recipient
Serious: 38/40 (95%)
Deaths: 11/40
Serious adverse events (78 terms)
| Reaction | System | CD34+ Cell Positively Sele… |
|---|---|---|
| Body temperature increased | Investigations | — |
| Acute graft versus host disease in intestine | Immune system disorders | — |
| Cytomegalovirus infection | Infections and infestations | — |
| Bacteraemia | Infections and infestations | — |
| Clostridium difficile infection | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| suspected infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Acute graft versus host disease in skin | Immune system disorders | — |
| Chronic graft versus host disease in intestine | Immune system disorders | — |
| Escherichia bacteraemia | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Fluid overload | Cardiac disorders | — |
| Adenovirus infection | Infections and infestations | — |
| BK virus infection | Infections and infestations | — |
| Escherichia sepsis | Infections and infestations | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Engraftment syndrome | Blood and lymphatic system disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Cardiomyopathy acute | Cardiac disorders | — |
| Diastolic dysfunction | Cardiac disorders | — |
| Tachycardia | Cardiac disorders | — |
Most-reported serious reactions: Body temperature increased, Acute graft versus host disease in intestine, Cytomegalovirus infection, Bacteraemia, Clostridium difficile infection, Pneumonia, suspected infection, Sepsis.
Data from ClinicalTrials.gov NCT01866839 adverse events section.
Sponsor's own description
Background: \- Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to test a blood separator machine that may help remove more of the donor's white blood cells before transplant. They will study donors and recipients during stem cell transplant to see how well this process can prevent GVHD and other complications. Objectives: \- To see if a new blood separator machine can improve outcomes of stem cell transplants. Eligibility: * Individuals between 10 and 75 years of age who are having a stem cell transplant for leukemia or other blood-related cancers. * Donors for the stem cell transplant. Design: * Recipients and donors will be screened with a physical exam and medical history. * Donors will have two blood collection procedures. The first will collect only white blood cells, and return the rest of the blood. After the first collection, participants will have filgrastim injections to help their stem cells enter their blood. Then, they will have a second blood collection for the stem cells. * Recipients will have radiation and chemotherapy to prepare for the stem cell transplant. They will then have the stem cell transplant with the donor cells that have been treated with the blood separator machine. * Recipients will be monitored closely after the procedure. They may receive some of their donor's white blood cells if needed to fight serious infections. * Recipients will have the regular standard of care after their transplant. Blood samples will be taken and any side effects will be monitored and treated.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Over-expression of PD-1 Does Not Predict Leukemic Relapse after Allogeneic Stem Cell Transplantation.
Jain P, Tian X, Cordes S, Chen J, et al · · 2019 · cited 10× · PMID 30292745 · DOI 10.1016/j.bbmt.2018.09.037 -
Distinct Biomarker Profiles in Ex Vivo T Cell Depletion Graft Manipulation Strategies: CD34<sup>+</sup> Selection versus CD3<sup>+</sup>/19<sup>+</sup> Depletion in Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation.
Cantilena CR, Ito S, Tian X, Jain P, et al · · 2018 · cited 2× · PMID 29197677 · DOI 10.1016/j.bbmt.2017.11.028 -
CD34+ selection and the severity of oropharyngeal mucositis in total body irradiation-based allogeneic stem cell transplantation.
Anand A, Anandi P, Jain NA, Lu K, et al · · 2016 · cited 2× · PMID 26190358 · DOI 10.1007/s00520-015-2848-9 -
Improved reproducibility and quality of GvHD biomarker assay: application of multiplex microfluidic channel system.
Anandi P, Tian X, Chinian F, Cantilena CR, et al · · 2016 · cited 1× · PMID 27595279 · DOI 10.1038/bmt.2016.226
Verify or expand the search:
- PubMed search for NCT01866839
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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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 NCT01866839 (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 National Heart, Lung, and Blood Institute (NHLBI)
- Last refreshed: 21 July 2020
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/NCT01866839.
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