Hematologic NeoplasmsABDNCT02193880

Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)

A study testing Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. in people with Hematologic Neoplasms and Graft-Versus-Host Disease, run by Ayman Saad at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of… Read more about this study

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Hematologic Neoplasms, Graft-Versus-Host Disease
What is being tested?: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 9 Oct 2014to 13 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Neoplastic hematological disorder with indication of allogeneic transplant
No available suitable HLA-matched donor
Adequate cardiac, pulmonary, renal, and hepatic function
Karnofsky performance status score greater than or equal to 70%

Who cannot join

Medication non-compliance
No appropriate caregiver identified
Uncontrolled medical or psychiatric disorder
Active central nervous system (CNS) neoplastic involvement
Known allergy to Dimethyl Sulfoxide
HIV1 or HIV2 positive
Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

UAB Medical Center (University of Alabama at Birmingham)
Birmingham, Alabama, 35233

Other trials in United States

About this study

Read the detailed description

Transplant patients participating in this clinical trial will receive one of 3 standard pre-transplant chemotherapy preparative regimens as appropriate for their specific disease. They will then receive a standard non-manipulated donor stem cell infusion on transplant day (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor stem cell infusion on day +7.

Conditions: Hematologic Neoplasms, Graft-Versus-Host Disease
Being tested: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Keywords: stem cell transplant
Medical subject headings: Hematologic Neoplasms, Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.Device
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Study groups in NCT02193880
Study group	Role	What they receive
Alpha-beta depleted T-cell infusion	Other	Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. Receives: Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Measured: From baseline and before day +100 of transplant.
Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.
Measured: From baseline and before day +100 of transplant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 201413 Mar 2018

First posted18 Jul 2014 (estimated)
Study start9 Oct 2014
Primary completion13 Mar 2018
Study completion13 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02193880
Sponsor's protocol ID: UAB 1397
Acronym: ABD
Status last verified: Apr 2019
First submitted: 14 Jul 2014
Last updated: 25 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Lee SJ, Klein J, Haagenson M, Baxter-Lowe LA, Confer DL, Eapen M, Fernandez-Vina M, Flomenberg N, Horowitz M, Hurley CK, Noreen H, Oudshoorn M, Petersdorf E, Setterholm M, Spellman S, Weisdorf D, Williams TM, Anasetti C. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood. 2007 Dec 15;110(13):4576-83. doi: 10.1182/blood-2007-06-097386. Epub 2007 Sep 4.
PubMed 17785583
Alshemmari S, Ameen R, Gaziev J. Haploidentical hematopoietic stem-cell transplantation in adults. Bone Marrow Res. 2011;2011:303487. doi: 10.1155/2011/303487. Epub 2011 Jul 13.
PubMed 22046559
Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006 Apr 27;354(17):1813-26. doi: 10.1056/NEJMra052638. No abstract available.
PubMed 16641398
Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7.
PubMed 15753458
Gale RP, Horowitz MM. Graft-versus-leukemia in bone marrow transplantation. The Advisory Committee of the International Bone Marrow Transplant Registry. Bone Marrow Transplant. 1990 Jul;6 Suppl 1:94-7.
PubMed 2390646
Horowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ, Rimm AA, Ringden O, Rozman C, Speck B, et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood. 1990 Feb 1;75(3):555-62.
PubMed 2297567
Ferrara JL, Yanik G. Acute graft versus host disease: pathophysiology, risk factors, and prevention strategies. Clin Adv Hematol Oncol. 2005 May;3(5):415-9, 428.
PubMed 16167015
Oevermann L, Handgretinger R. New strategies for haploidentical transplantation. Pediatr Res. 2012 Apr;71(4 Pt 2):418-26. doi: 10.1038/pr.2011.60. Epub 2012 Jan 25.
PubMed 22278184
Lamb LS Jr, Lopez RD. gammadelta T cells: a new frontier for immunotherapy? Biol Blood Marrow Transplant. 2005 Mar;11(3):161-8. doi: 10.1016/j.bbmt.2004.11.015.
PubMed 15744234
Moretta L, Locatelli F, Pende D, Marcenaro E, Mingari MC, Moretta A. Killer Ig-like receptor-mediated control of natural killer cell alloreactivity in haploidentical hematopoietic stem cell transplantation. Blood. 2011 Jan 20;117(3):764-71. doi: 10.1182/blood-2010-08-264085. Epub 2010 Oct 1.
PubMed 20889923
Palmer JM, Rajasekaran K, Thakar MS, Malarkannan S. Clinical relevance of natural killer cells following hematopoietic stem cell transplantation. J Cancer. 2013;4(1):25-35. doi: 10.7150/jca.5049. Epub 2012 Dec 5.
PubMed 23386902
Lamb LS Jr, Henslee-Downey PJ, Parrish RS, Godder K, Thompson J, Lee C, Gee AP. Increased frequency of TCR gamma delta + T cells in disease-free survivors following T cell-depleted, partially mismatched, related donor bone marrow transplantation for leukemia. J Hematother. 1996 Oct;5(5):503-9. doi: 10.1089/scd.1.1996.5.503.
PubMed 8938522
Lamb LS Jr, Gee AP, Hazlett LJ, Musk P, Parrish RS, O'Hanlon TP, Geier SS, Folk RS, Harris WG, McPherson K, Lee C, Henslee-Downey PJ. Influence of T cell depletion method on circulating gammadelta T cell reconstitution and potential role in the graft-versus-leukemia effect. Cytotherapy. 1999;1(1):7-19. doi: 10.1080/0032472031000141295.
PubMed 19746645
Godder KT, Henslee-Downey PJ, Mehta J, Park BS, Chiang KY, Abhyankar S, Lamb LS. Long term disease-free survival in acute leukemia patients recovering with increased gammadelta T cells after partially mismatched related donor bone marrow transplantation. Bone Marrow Transplant. 2007 Jun;39(12):751-7. doi: 10.1038/sj.bmt.1705650. Epub 2007 Apr 23.
PubMed 17450185
Handgretinger R. New approaches to graft engineering for haploidentical bone marrow transplantation. Semin Oncol. 2012 Dec;39(6):664-73. doi: 10.1053/j.seminoncol.2012.09.007.
PubMed 23206843

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
ClinicalTrials.gov ID: NCT02193880
Acronym / sponsor ID: ABD / UAB 1397
Conditions: Hematologic Neoplasms, Graft-Versus-Host Disease
Keywords: stem cell transplant
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Ayman SaadUniversity, hospital or other
Study start: 9 Oct 2014 (actual)
Primary completion: 13 Mar 2018 (actual)
Study completion: 13 Mar 2018 (actual)
First posted: 18 Jul 2014 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Alpha-beta depleted T-cell infusion	Other	Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Neoplastic hematological disorder with indication of allogeneic transplant
No available suitable HLA-matched donor
Adequate cardiac, pulmonary, renal, and hepatic function
Karnofsky performance status score greater than or equal to 70%

Key exclusion criteria (7 listed)

Medication non-compliance
No appropriate caregiver identified
Uncontrolled medical or psychiatric disorder
Active central nervous system (CNS) neoplastic involvement
Known allergy to Dimethyl Sulfoxide

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.	Device	Alpha-beta depleted T-cell infusion

Primary outcome

Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
Time frame: From baseline and before day +100 of transplant.
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
Time frame: From baseline and before day +100 of transplant.
Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alpha-beta Depleted T-cell Infusion	7	4

Primary outcome: Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)

Time frame: From baseline and before day +100 of transplant.. Count of participants. Unit: Participants

Measure	Alpha-beta Depleted T-cell Infusion n = 4
Value	0

Population analysed: we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT..

Primary outcome: Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)

Time frame: From baseline and before day +100 of transplant.. Count of participants. Unit: Participants

Measure	Alpha-beta Depleted T-cell Infusion n = 4
Value	0

Population analysed: we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.

Adverse events

Time frame: Baseline through one year.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alpha-beta Depleted T-cell Infusion	2 of 4 (50%)	2 of 4 (50%)	3 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17785583Lee SJ, Klein J, Haagenson M, Baxter-Lowe LA, Confer DL, Eapen M, Fernandez-Vina M, Flomenberg N, Horowitz M, Hurley CK, Noreen H, Oudshoorn M, Petersdorf E, Setterholm M, Spellman S, Weisdorf D, Williams TM, Anasetti C. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood. 2007 Dec 15;110(13):4576-83. doi: 10.1182/blood-2007-06-097386. Epub 2007 Sep 4.
Background: PubMed 22046559Alshemmari S, Ameen R, Gaziev J. Haploidentical hematopoietic stem-cell transplantation in adults. Bone Marrow Res. 2011;2011:303487. doi: 10.1155/2011/303487. Epub 2011 Jul 13.
Background: PubMed 16641398Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006 Apr 27;354(17):1813-26. doi: 10.1056/NEJMra052638. No abstract available.
Background: PubMed 15753458Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7.
Background: PubMed 2390646Gale RP, Horowitz MM. Graft-versus-leukemia in bone marrow transplantation. The Advisory Committee of the International Bone Marrow Transplant Registry. Bone Marrow Transplant. 1990 Jul;6 Suppl 1:94-7.
Background: PubMed 2297567Horowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ, Rimm AA, Ringden O, Rozman C, Speck B, et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood. 1990 Feb 1;75(3):555-62.
Background: PubMed 16167015Ferrara JL, Yanik G. Acute graft versus host disease: pathophysiology, risk factors, and prevention strategies. Clin Adv Hematol Oncol. 2005 May;3(5):415-9, 428.
Background: PubMed 22278184Oevermann L, Handgretinger R. New strategies for haploidentical transplantation. Pediatr Res. 2012 Apr;71(4 Pt 2):418-26. doi: 10.1038/pr.2011.60. Epub 2012 Jan 25.
Background: PubMed 15744234Lamb LS Jr, Lopez RD. gammadelta T cells: a new frontier for immunotherapy? Biol Blood Marrow Transplant. 2005 Mar;11(3):161-8. doi: 10.1016/j.bbmt.2004.11.015.
Background: PubMed 20889923Moretta L, Locatelli F, Pende D, Marcenaro E, Mingari MC, Moretta A. Killer Ig-like receptor-mediated control of natural killer cell alloreactivity in haploidentical hematopoietic stem cell transplantation. Blood. 2011 Jan 20;117(3):764-71. doi: 10.1182/blood-2010-08-264085. Epub 2010 Oct 1.
Background: PubMed 23386902Palmer JM, Rajasekaran K, Thakar MS, Malarkannan S. Clinical relevance of natural killer cells following hematopoietic stem cell transplantation. J Cancer. 2013;4(1):25-35. doi: 10.7150/jca.5049. Epub 2012 Dec 5.
Background: PubMed 8938522Lamb LS Jr, Henslee-Downey PJ, Parrish RS, Godder K, Thompson J, Lee C, Gee AP. Increased frequency of TCR gamma delta + T cells in disease-free survivors following T cell-depleted, partially mismatched, related donor bone marrow transplantation for leukemia. J Hematother. 1996 Oct;5(5):503-9. doi: 10.1089/scd.1.1996.5.503.
Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayman Saad, MD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) (time frame: From baseline and before day +100 of transplant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02193880, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.