Non-Hodgkin's Lymphoma (NHL)Phase 1/2NCT00089284

Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL

A Phase 1/2 study testing Rituxan, motexafin gadolinium and 111Indium-Zevalin and 90Yttrium-Zevalin in people with Non-Hodgkin's Lymphoma (NHL), run by Northwestern University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Hodgkin's Lymphoma (NHL)
What is being tested?: Rituxan, motexafin gadolinium and 111Indium-Zevalin and 90Yttrium-Zevalin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesUnited States
Study dates: 28 Oct 2003to 20 Aug 2008
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks
No active infection
No other active nonmalignant disease
No known G6PD deficiency
No history of porphyria
No other condition that would preclude study participation

Show all 15Show fewer

No human anti-mouse antibodies
No known history of HIV
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior radioimmunoconjugate therapy
No prior exposure to murine antibodies other than rituximab
More than 4 weeks since prior rituximab
No history of failed stem cell collection

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Northwestern University
Chicago, Illinois, 60611-3013
Jesse B. Brown Veterans Affairs Medical Center
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkin's Lymphoma (NHL): Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent, Motexafin Gadolinium (MGd)

Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.

This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II, stage III, or stage IV relapsed or refractory non-Hodgkin's lymphoma.

Read the detailed description

This is a phase I, dose-escalation study of motexafin gadolinium followed by a phase II study. Patients are stratified according to extent of lymphomatous involvement (≤ 5% vs > 5 but ≤ 24% of cellular elements).

Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity (DLT) OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT.

Once the MTD is determined, additional patients are treated at that dose level as in phase I.

Patients are followed weekly for 3 months and then monthly for 5 years.

Conditions: Non-Hodgkin's Lymphoma (NHL)
Being tested: Rituxan, motexafin gadolinium, 111Indium-Zevalin and 90Yttrium-Zevalin
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

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

RituxanDrug
Also called rituximab IDEC-C2B8
Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
motexafin gadoliniumDrug
Also called MGd, Xcytrin® (motexafin gadolinium) Injection,, NSC 695238
Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
111Indium-Zevalin and 90Yttrium-ZevalinDrug
Also called Ibritumomab-tiuxetan
Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.

Study groups in NCT00089284
Study group	Role	What they receive
Rituxan and 90Yttrium-Zevalin plus MGd	Experimental	Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2, 4, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8. Receives: Drug: Rituxan; Drug: motexafin gadolinium; Drug: 111Indium-Zevalin and 90Yttrium-Zevalin

What is being measured

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

Dose Limiting Toxicities (DLT)
The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients.
All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following:
Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively).
Measured: Weekly during treatment and continuing up through Day 90
Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients.
Measured: Weekly during treatment and continuing up through Day 90

Secondary outcomes (3)

Anti-lymphoma Efficacy
To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined.
Measured: At 1, 3 and 6 months
Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs
To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement.
Measured: At baseline (pre-treatment) and on Day 4 of treatment
Correlative Laboratory Studies
To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations).
Measured: On Day 1 and 4

Timeline

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

28 Oct 200320 Aug 2008

First posted5 Aug 2004 (estimated)
Study start28 Oct 2003
Primary completionJan 2007
Study completion20 Aug 2008

Why it stopped: Due to lack of funding, phase II of study was not completed.

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.
Other trials for Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00089284
Sponsor's protocol ID: NU 02H8
Other IDs: 1346001
Status last verified: Apr 2019
First submitted: 4 Aug 2004
Last updated: 14 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma

All Non-Hodgkin's Lymphoma (NHL) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkin's Lymphoma (NHL): Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent, Motexafin Gadolinium (MGd)
ClinicalTrials.gov ID: NCT00089284
Acronym / sponsor ID: NU 02H8
Conditions: Non-Hodgkin's Lymphoma (NHL)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to lack of funding, phase II of study was not completed.
Enrolment: 30 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Robert H. Lurie Cancer Center
Study start: 28 Oct 2003 (actual)
Primary completion: Jan 2007 (actual)
Study completion: 20 Aug 2008 (actual)
First posted: 5 Aug 2004 (estimated)
Results: Posted 14 Aug 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

Once the MTD is determined, additional patients are treated at that dose level as in phase I.

Patients are followed weekly for 3 months and then monthly for 5 years.

Study design

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

Arm	Type	Receives
Rituxan and 90Yttrium-Zevalin plus MGd	Experimental	Drug: Rituxan, Drug: motexafin gadolinium, Drug: 111Indium-Zevalin and 90Yttrium-ZevalinPatients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2, 4, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (15 listed)

No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks
No active infection
No other active nonmalignant disease
No known G6PD deficiency
No history of porphyria

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
RituxanAlso: rituximab IDEC-C2B8Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2, 4, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.	Drug	Rituxan and 90Yttrium-Zevalin plus MGd
motexafin gadoliniumAlso: MGd, Xcytrin® (motexafin gadolinium) Injection,, NSC 695238Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2, 4, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.	Drug	Rituxan and 90Yttrium-Zevalin plus MGd
111Indium-Zevalin and 90Yttrium-ZevalinAlso: Ibritumomab-tiuxetanPatients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2, 4, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.	Drug	Rituxan and 90Yttrium-Zevalin plus MGd

Primary outcome

Dose Limiting Toxicities (DLT)
Time frame: Weekly during treatment and continuing up through Day 90
The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively).
Maximum Tolerated Dose (MTD)
Time frame: Weekly during treatment and continuing up through Day 90
The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients.

3 secondary outcomes

Anti-lymphoma Efficacy
Time frame: At 1, 3 and 6 months
Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs
Time frame: At baseline (pre-treatment) and on Day 4 of treatment
Correlative Laboratory Studies
Time frame: On Day 1 and 4

Results and safety

Results posted to the registry on 14 Aug 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
Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement	7	7
Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement	3	3
Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement	6	6
Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement	6	6
Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement	0	0
Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement	0	0
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement	8	7

Primary outcome: Dose Limiting Toxicities (DLT)

Time frame: Weekly during treatment and continuing up through Day 90. Number. Unit: Dose-Limiting Toxicities

Measure	2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement n = 7	2.5 mg/kg MGd & 6-24% Bone Marrow Involvement n = 3	3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement n = 6	5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement n = 6	3.5 mg/kg MGd & 6-24% Bone Marrow Involvement n = 0	5.0 mg/kg MGd & 6-24% Bone Marrow Involvement n = 0
Value	0	0	0	0	–	–

Population analysed: Only patients enrolled during the phase I portion of this trial were analyzed for this outcome measure.

Primary outcome: Maximum Tolerated Dose (MTD)

Time frame: Weekly during treatment and continuing up through Day 90. Number. Unit: mg/kg

Measure	Rituxan and 90Yttrium-Zevalin Plus MGd n = 22
Value	5.0

Population analysed: Phase I arms were evaluable for this outcome measure.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement	0 of 7 (0%)	7 of 7 (100%)	Not reported
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement	4 of 13 (30.8%)	13 of 13 (100%)	Not reported
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement	0 of 0	0 of 0	Not reported
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Due to a lack of adequate funding, we were unable to complete 2 of the secondary objectives for this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-Hodgkin's Lymphoma (NHL)

RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma

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.

Andrew M. Evens, DO, MS principal investigator

Northwestern University

Leo I. Gordon, MD principal investigator

Northwestern University

2 sites 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 0 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 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?

Dose Limiting Toxicities (DLT) (time frame: Weekly during treatment and continuing up through Day 90). 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 NCT00089284.

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 14 Aug 2019.